Implants for surgery - Metallic
8-150 Mat materials - Part 9: Wrought high
nitrogen stainless steel
5832-9:2007 09/09/2008 ISO
Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 8-150: ISO 5832-9:2007, Implants for surgery - Metallic
materials - Part 9: Wrought high nitrogen stainless steel. (Materials)
Date of Standard: 2007.
Address of Standards Organization:
International Organization for Standardization (ISO)*
1, Rue de Varembe
Case Postale 56
CH 1211 Geneva 20, 0
SWITZERLAND
CDRH Offices and Divisions Associated with Recognized Standards:
(1) OFFICE OF DEVICE EVALUATION (ODE)
(2) OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Implantable Medical Devices
Processes Affected:
510(K), PMA, IDE, PDP, HDE, Design Controls
Type of Standard:
Horizontal, International
Extent of Recognition:
This standard includes requirements for chemical composition, metallurgical
characteristics, and mechanical properties in various conditions. The standard has no
specific requirements regarding biologic response. Refer to the appropriate
biocompatibility standards for specific biocompatibility requirements. Additional
information must be provided to document that the design of the product will
provide adequate mechanical properties for the particular application. Depending on
the device application, additional material property data (such as fatigue life, wear
and abrasion resistance, pitting or crevice corrosion resistance, and magnetic
susceptibility) may be required beyond what is addressed by this standard.
Related CFR Citations
and Product Codes:
Regulation
Device Name
Number
§872.313021
Device Name
Number
§872.316523
Device Name
Number
§872.324025
Device Name
Number
§872.3285
27
Device Name
Number
§872.333029
Regulation
Device
Class
Device
Class
Class 1
Clasp, Preformed
Regulation
Class
Class 1
Bur, Dental
Regulation
Device
Class 1
Attachment, Precision, All
Regulation
Class
Class 1
Anchor, Preformed
Regulation
Device
Device
Class
Class 1
Crown, Preformed
Device Name
Device
Product
Code
EJX22
Product
Code
EGG24
Product
Code
EJL26
Product
Code
28
EHP
Product
Code
ELZ30
Product
Number
Class
§872.335031
Cusp, Gold And Stainless Steel
Regulation
Device Name
Number
§872.3360
33
Device Name
Number
§872.3580
35
Teeth, Preformed Gold Denture
Regulation
Device Name
Number
§872.374037
Pin, Retentive And Splinting, And Accessory Instruments
Regulation
Device Name
Number
§872.381039
Device Name
Number
§872.390041
Teeth, Artificial, Posterior With Metal Insert
Regulation
Device Name
Number
Class
Device
Class
Class 1
Device
Class
Class 1
Device
Class
Class 1
Post, Root Canal
Regulation
Device
Class 1
Cusp, Preformed
Regulation
Class 1
Device
Class
Class 1
Device
Class
Code
ELO32
Product
Code
EHQ34
Product
Code
ELN
36
Product
Code
EBL38
Product
Code
ELR40
Product
Code
ELJ42
Product
Code
§872.412043
Drill, Bone, Powered
Class 2
DZI44
§872.412045
Driver, Wire, And Bone Drill, Manual
Class 2
DZJ46
§872.412047
Handpiece, Rotary Bone Cutting
Class 2
KMW48
§872.412049
Saw, Bone, Ac-Powered
Class 2
DZH50
Regulation
Device Name
Number
§872.413051
Drill, Dental, Intraoral
Device
Class
Class 1
Product
Code
DZA52
Regulation
Device Name
Number
Device
Class
Product
Code
§872.420053
Handpiece, Air-Powered, Dental
Class 1
EFB54
§872.420055
Handpiece, Belt And/Or Gear Driven, Dental
Class 1
EFA56
§872.420057
Handpiece, Contra- And Right-Angle Attachment, Dental
Class 1
EGS58
Regulation
Device Name
Number
Device
Class
Product
Code
59
Accessories, Retractor, Dental
Class 1
EIF
§872.456561
Aligner, Bracket, Orthodontic
Class 1
ECQ62
§872.456563
Broach, Endodontic
Class 1
EKW64
§872.456565
Burnisher, Operative
Class 1
EKJ66
§872.456567
Carrier, Amalgam, Operative
Class 1
EKI68
§872.456569
Chisel, Bone, Surgical
Class 1
EML70
§872.456571
Chisel, Osteotome, Surgical
Class 1
EMM72
§872.456573
Condenser, Amalgam And Foil, Operative
Class 1
EKG74
§872.456575
Curette, Endodontic
Class 1
EKT76
§872.456577
Curette, Operative
Class 1
EKE78
§872.456579
Curette, Periodontic
Class 1
EMS80
§872.456581
Curette, Surgical, Dental
Class 1
EMK82
§872.456583
Dental Lapping Tool Kit
Class 1
NYG84
§872.456585
Driver, Band, Orthodontic
Class 1
ECT86
§872.456587
Elevator, Surgical, Dental
Class 1
EMJ88
§872.456589
Excavator, Dental, Operative
Class 1
EKC90
§872.456591
Explorer, Operative
Class 1
EKB92
93
File, Bone, Surgical
Class 1
EMI
§872.456595
File, Margin Finishing, Operative
Class 1
EKA96
§872.456597
File, Periodontic
Class 1
EMR98
§872.456599
File, Pulp Canal, Endodontic
Class 1
EKS100
§872.4565101
Forceps, Articulation Paper
Class 1
EFK102
§872.4565103
Forceps, Dressing, Dental
Class 1
EFL104
§872.4565105
Forceps, Rongeur, Surgical
Class 1
EMH106
§872.4565
§872.4565
60
94
§872.4565107
Forceps, Tooth Extractor, Surgical
Class 1
EMG108
§872.4565109
Gauge, Depth, Instrument, Dental
Class 1
EIL110
§872.4565111
Handle, Instrument, Dental
Class 1
EJB112
§872.4565113
Hemostat, Surgical
Class 1
EMD114
§872.4565115
Hoe, Periodontic
Class 1
EMQ116
§872.4565117
Instrument, Contouring, Matrix, Operative
Class 1
EKF118
§872.4565119
Instrument, Cutting, Operative
Class 1
EKD120
§872.4565121
Instrument, Filling, Plastic, Dental
Class 1
EIY122
§872.4565123
Instrument, Hand, Calculus Removal
Class 1
ELA124
§872.4565125
Instrument, Ligature Tucking, Orthodontic
Class 1
ECP126
§872.4565127
Instruments, Dental Hand
Class 1
DZN128
§872.4565129
Knife, Margin Finishing, Operative
Class 1
EJZ130
§872.4565131
Knife, Periodontic
Class 1
EMO132
§872.4565133
Marker, Periodontic
Class 1
EMP134
§872.4565135
Mirror, Mouth
Class 1
EAX136
§872.4565137
Parallelometer
Class 1
EGI138
§872.4565139
Plier, Orthodontic
Class 1
JEX140
§872.4565141
Pliers, Operative
Class 1
EJY142
§872.4565143
Plugger, Root Canal, Endodontic
Class 1
EKR144
§872.4565145
Preparer, Root Canal Endodontic
Class 1
EKQ146
§872.4565147
Probe, Periodontic
Class 1
EIX148
§872.4565149
Punch, Biopsy, Surgical
Class 1
EME150
§872.4565151
Pusher, Band, Orthodontic
Class 1
ECS152
§872.4565153
Reamer, Pulp Canal, Endodontic
Class 1
EKP154
§872.4565155
Remover, Crown
Class 1
EIS156
§872.4565157
Retainer, Matrix
Class 1
JEP158
§872.4565159
Retractor, All Types
Class 1
EIG160
§872.4565161
Scaler, Periodontic
Class 1
EMN162
§872.4565163
Scissors, Collar And Crown
Class 1
EIR164
§872.4565165
Scissors, Surgical Tissue, Dental
Class 1
EGN166
§872.4565167
Setter, Band, Orthodontic
Class 1
ECR168
§872.4565169
Spreader, Pulp Canal Filling Material, Endodontic
Class 1
EKK170
§872.4565171
Syringe, Irrigating (Dental)
Class 1
EIB172
§872.4565173
Syringe, Periodontic, Endodontic, Irrigating
Class 1
EIC174
§872.4565175
Syringe, Restorative And Impression Material
Class 1
EID176
§872.4565177
Unit, Syringe, Air And/Or Water
Class 1
ECB178
Regulation
Device Name
Number
§872.4600179
Lock, Wire, And Ligature, Intraoral
Regulation
Device Name
Number
Device
Class
Class 2
Device
Class
Product
Code
DYX180
Product
Code
§872.4760181
External Mandibular Fixator And/Or Distractor
Class 2
MQN182
§872.4760183
Implant, Transmandibular
Class 2
MDL184
§872.4760185
Plate, Bone
Class 2
JEY186
Regulation
Device Name
Number
§872.4880187
Screw, Fixation, Intraosseous
Regulation
Device Name
Number
Device
Class
Class 2
Device
Class
Product
Code
DZL188
Product
Code
§872.5410189
Band, Elastic, Orthodontic
Class 1
ECI190
§872.5410191
Band, Material, Orthodontic
Class 1
DYO192
§872.5410193
Band, Preformed, Orthodontic
Class 1
ECM194
§872.5410195
Bracket, Metal, Orthodontic
Class 1
EJF196
§872.5410197
Bracket, Metal, Orthodontic, Reprocessed
Class 1
NQS198
§872.5410199
Clamp, Wire, Orthodontic
Class 1
ECN200
§872.5410201
Retainer, Screw Expansion, Orthodontic
Class 1
DYJ202
§872.5410203
Spring, Orthodontic
Class 1
ECO204
§872.5410205
Tube, Orthodontic
Class 1
DZD206
§872.5410207
Wire, Orthodontic
Class 1
DZC208
Regulation
Device Name
Device
Product
Number
§872.5500209
Class
Headgear, Extraoral, Orthodontic
Class 2
Code
DZB210
No Product Code information listed for §888.3XXX211, Metallic components of all
implantables
Relevant Guidance:
There is no relevant guidance developed at this time.
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3130]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3130 Preformed anchor.
(a)Identification. A preformed anchor is a device made of austenitic alloys
or alloys containing 75 percent or greater gold or metals of the platinum
group intended to be incorporated into a dental appliance, such as a
denture, to help stabilize the appliance in the patient's mouth.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66
FR 38797, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3165]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3165 Precision attachment.
(a)Identification. A precision attachment or preformed bar is a device
made of austenitic alloys or alloys containing 75 percent or greater gold
and metals of the platinum group intended for use in prosthetic dentistry
in conjunction with removable partial dentures. Various forms of the device
are intended to connect a lower partial denture with another lower partial
denture, to connect an upper partial denture with another upper partial
denture, to connect either an upper or lower partial denture to a tooth
or a crown, or to connect a fixed bridge to a partial denture.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66
FR 38797, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3240]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3240 Dental bur.
(a)Identification. A dental bur is a rotary cutting device made from carbon
steel or tungsten carbide intended to cut hard structures in the mouth,
such as teeth or bone. It is also intended to cut hard metals, plastics,
porcelains, and similar materials intended for use in the fabrication of
dental devices.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66
FR 38798, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3285]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3285 Preformed clasp.
(a)Identification. A preformed clasp or a preformed wire clasp is a
prefabricated device made of austenitic alloys or alloys containing 75
percent or greater gold and metals of the platinum group intended to be
incorporated into a dental appliance, such as a partial denture, to help
stabilize the appliance in the patient's mouth by fastening the appliance
to an adjacent tooth.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66
FR 38798, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3330]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3330 Preformed crown.
(a)Identification. A preformed crown is a prefabricated device made of
plastic or austenitic alloys or alloys containing 75 percent or greater
gold and metals of the platinum group intended to be affixed temporarily
to a tooth after removal of, or breakage of, the natural crown (that portion
of the tooth that normally protrudes above the gums). It is intended for
use as a functional restoration until a permanent crown is constructed.
The device also may be intended for use as a functional restoration for
a badly decayed deciduous (baby) tooth until the adult tooth erupts.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66
FR 38798, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3350]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3350 Gold or stainless steel cusp.
(a)Identification. A gold or stainless steel cusp is a prefabricated device
made of austenitic alloys or alloys containing 75 percent or greater gold
and metals of the platinum group or stainless steel intended to provide
a permanent cusp (a projection on the chewing surface of a tooth) to achieve
occlusal harmony (a proper bite) between the teeth and a removable denture.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66
FR 38798, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3360]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3360 Preformed cusp.
(a)Identification. A performed cusp is a prefabricated
device made of plastic or austenitic alloys or alloys
containing 75 percent or greater gold and metals of the
platinum group intended to be used as a temporary cusp
(a projection on the chewing surface of a tooth) to
achieve occlusal harmony (a proper bite) before
permanent restoration of a tooth.
(b)Classification. Class I (general controls). The
device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter
subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008,
Dec. 7, 1994; 66 FR 38798, July 25, 2001]
-
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3580]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3580 Preformed gold denture tooth.
(a)Identification. A preformed gold denture tooth is a device composed
of austenitic alloys or alloys containing 75 percent or greater gold and
metals of the platinum group intended for use as a tooth or a portion of
a tooth in a fixed or removable partial denture.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66
FR 38798, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3740]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3740 Retentive and splinting pin.
(a)Identification. A retentive and splinting pin is a device made of
austenitic alloys or alloys containing 75 percent or greater gold and
metals of the platinum group intended to be placed permanently in a tooth
to provide retention and stabilization for a restoration, such as a crown,
or to join two or more teeth together.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9
[52 FR 30097, Aug. 12, 1987, as amended at 60 FR 38900, July 28, 1995;
66 FR 38798, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3810]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3810 Root canal post.
(a)Identification. A root canal post is a device made of austenitic alloys
or alloys containing 75 percent or greater gold and metals of the platinum
group intended to be cemented into the root canal of a tooth to stabilize
and support a restoration.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 60 FR 38900, July 28, 1995;
66 FR 38798, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.3900]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart D--Prosthetic Devices
Sec. 872.3900 Posterior artificial tooth with a metal insert.
(a)Identification. A posterior artificial tooth with a metal insert is
a porcelain device with an insert made of austenitic alloys or alloys
containing 75 percent or greater gold and metals of the platinum group
intended to replace a natural tooth. The device is attached to surrounding
teeth by a bridge and is intended to provide both an improvement in
appearance and functional occlusion (bite).
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66
FR 38798, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.4120]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart E--Surgical Devices
Sec. 872.4120 Bone cutting instrument and accessories.
(a)Identification. A bone cutting instrument and accessories is a metal
device intended for use in reconstructive oral surgery to drill or cut
into the upper or lower jaw and may be used to prepare bone to insert a
wire, pin, or screw. The device includes the manual bone drill and wire
driver, powered bone drill, rotary bone cutting handpiece, and AC-powered
bone saw.
(b)Classification. Class II.
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.4130]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart E--Surgical Devices
Sec. 872.4130 Intraoral dental drill.
(a)Identification. An intraoral dental drill is a rotary device intended
to be attached to a dental handpiece to drill holes in teeth to secure
cast or preformed pins to retain operative dental appliances.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66
FR 38799, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.4200]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart E--Surgical Devices
Sec. 872.4200 Dental handpiece and accessories.
(a)Identification. A dental handpiece and accessories is an AC-powered,
water-powered, air-powered, or belt-driven, hand-held device that may
include a foot controller for regulation of speed and direction of rotation
or a contra-angle attachment for difficult to reach areas intended to
prepare dental cavities for restorations, such as fillings, and for
cleaning teeth.
(b)Classification. Class I.
[55 FR 48439, Nov. 20, 1990]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.4565]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart E--Surgical Devices
Sec. 872.4565 Dental hand instrument.
(a)Identification. A dental hand instrument is a
hand-held device intended to perform various tasks in
general dentistry and oral surgery procedures. The
device includes the operative burnisher, operative
amalgam carrier, operative dental amalgam carver,
surgical bone chisel, operative amalgam and foil
condenser, endodontic curette, operative curette,
periodontic curette, surgical curette, dental surgical
elevator, operative dental excavator, operative
explorer surgical bone file, operative margin
finishing file, periodontic file, periodontic probe,
surgical rongeur forceps, surgical tooth extractor
forceps, surgical hemostat, periodontic hoe, operative
matrix contouring instrument, operative cutting
instrument, operative margin finishing periodontic
knife, periodontic marker, operative pliers,
endodontic root canal plugger, endodontic root canal
preparer, surgical biopsy punch, endodontic pulp canal
reamer, crown remover, periodontic scaler, collar and
crown scissors, endodontic pulp canal filling material
spreader, surgical osteotome chisel, endodontic
broach, dental wax carver, endodontic pulp canal file,
hand instrument for calculus removal, dental depth
gauge instrument, plastic dental filling instrument,
dental instrument handle, surgical tissue scissors,
mouth mirror, orthodontic band driver, orthodontic
band pusher, orthodontic band setter, orthodontic
bracket aligner, orthodontic pliers, orthodontic
ligature tucking instrument, forceps, for articulation
paper, forceps for dental dressing, dental matrix band,
matrix retainer, dental retractor, dental retractor
accessories, periodontic or endodontic irrigating
syringe, and restorative or impression material
syringe.
(b)Classification. Class I (general controls). If the
device is made of the same materials that were used in
the device before May 28, 1976, it is exempt from the
premarket notification procedures in subpart E of part
807 of this chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830,
Apr. 5, 1989; 66 FR 38799, July 25, 2001]
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[Code of Federal Regulations]
[Title 21, Volume 8]
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[Revised as of April 1, 2013]
[CITE: 21CFR872.4600]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart E--Surgical Devices
Sec. 872.4600 Intraoral ligature and wire lock.
(a)Identification. An intraoral ligature and wire lock is a metal device
intended to constrict fractured bone segments in the oral cavity. The bone
segments are stabilized by wrapping the ligature (wire) around the
fractured bone segments and locking the ends together.
(b)Classification. Class II.
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.4760]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart E--Surgical Devices
Sec. 872.4760 Bone plate.
(a)Identification. A bone plate is a metal device intended to stabilize
fractured bone structures in the oral cavity. The bone segments are
attached to the plate with screws to prevent movement of the segments.
(b)Classification. Class II.
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.4880]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart E--Surgical Devices
Sec. 872.4880 Intraosseous fixation screw or wire.
(a)Identification. An intraosseous fixation screw or
wire is a metal device intended to be inserted into
fractured jaw bone segments to prevent their movement.
(b)Classification. Class II.
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[Revised as of April 1, 2013]
[CITE: 21CFR872.5410]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart F--Therapeutic Devices
Sec. 872.5410 Orthodontic appliance and accessories.
(a)Identification. An orthodontic appliance and accessories is a device
intended for use in orthodontic treatment. The device is affixed to a tooth
so that pressure can be exerted on the teeth. This device includes the
preformed orthodontic band, orthodontic band material, orthodontic
elastic band, orthodontic metal bracket, orthodontic wire clamp,
preformed orthodontic space maintainer, orthodontic expansion screw
retainer, orthodontic spring, orthodontic tube, and orthodontic wire.
(b)Classification. Class I (general controls). The device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to the limitations in 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66
FR 38799, July 25, 2001]
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR872.5500]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 872 -- DENTAL DEVICES
Subpart F--Therapeutic Devices
Sec. 872.5500 Extraoral orthodontic headgear.
(a)Identification. An extraoral orthodontic headgear is a device intended
for use with an orthodontic appliance to exert pressure on the teeth from
outside the mouth. The headgear has a strap intended to wrap around the
patient's neck or head and an inner bow portion intended to be fastened
to the orthodontic appliance in the patient's mouth.
(b)Classification. Class II.