Recognized Consensus Standards

Recognition List Number: 028 Publication Date: 03/16/2012

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 4-179: ISO 7405 Second edition 2008-12-15, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. (Dental/ENT)

Date of Standard: 2008.

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 COMPLIANCE (OC)

Devices Affected:

All dental devices which enter the oral cavity

Processes Affected:

510(k), PMA, IDE, HDE, PDP

Type of Standard:

International, Horizontal

Extent of Recognition:

Complete standard. Data from the test methods in the standard is needed. Additional testing may be necessary for some products.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Device, Electrical Dental Anesthesia	Class U	LWM
Unclassified	Laser, Dental	Class U	LYB
Unclassified	Locator, Root Apex	Class U	LQY
Unclassified	Saliva, Artificial	Class U	LFD
§872.3060	Applicator, Rapid Wax, Dental	Class 2	EIT
§872.3150	Ink, Arch Tracing	Class 1	KZO
§872.3750	Solution, Cement Disolving	Class 2	KZP
§872.3920	Teeth, Porcelain	Class 2	ELL
§872.3930	Bone Grafting Material, For Dental Bone Repair	Class 2	LPK
§872.4565	Parallelometer	Class 1	EGI
§872.4760	External Mandibular Fixator And/Or Distractor	Class 2	MQN
§872.4760	Implant, Transmandibular	Class 2	MDL
§872.5570	Device, Anti-Snoring	Class 2	LRK
§872.5570	Device, Jaw Repositioning	Class 2	LQZ
§872.6650	Tip, Rubber, Oral Hygiene	Class 1	JEW
§872.6855	Eraser, Dental Stain	Class 1	MAU
§872.6855	Scraper, Tongue	Class 1	LCN
§872.6865	Toothbrush, Ionic, Battery-Powered	Class 1	MMD
§878.3500	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction	Class 2	KKY
§884.4520	Pelvimeter, External	Class 1	HER
§890.3475	Device, Finger-Sucking	Class 1	LQX

Regulation Number	Device Name	Device Class	Product Code
§872.1720	Tester, Pulp	Class 2	EAT

Regulation Number	Device Name	Device Class	Product Code
§872.1740	Device, Caries Detection	Class 2	LFC

Regulation Number	Device Name	Device Class	Product Code
§872.3070	Alloy, Amalgam	Class 2	EJJ

Regulation Number	Device Name	Device Class	Product Code
§872.3060	Alloy, Gold-Based Noble Metal	Class 2	EJT
§872.3060	Alloy, Other Noble Metal	Class 2	EJS

Regulation Number	Device Name	Device Class	Product Code
§872.3200	Agent, Tooth Bonding, Resin	Class 2	KLE

Regulation Number	Device Name	Device Class	Product Code
§872.3250	Liner, Cavity, Calcium Hydroxide	Class 2	EJK

Regulation Number	Device Name	Device Class	Product Code
§872.3260	Varnish, Cavity	Class 2	LBH

Regulation Number	Device Name	Device Class	Product Code
§872.3275	Cement, Dental	Class 2	EMA

Regulation Number	Device Name	Device Class	Product Code
§872.3300	Coating, Denture Hydrophilic, Resin	Class 2	EBE

Regulation Number	Device Name	Device Class	Product Code
§872.3310	Coating, Filling Material, Resin	Class 2	EBD

Regulation Number	Device Name	Device Class	Product Code
§872.3400	Adhesive, Denture, Acacia And Karaya With Sodium Borate	Class 1	KOM
§872.3400	Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight	Class 3	MMU

Regulation Number	Device Name	Device Class	Product Code
§872.3420	Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer	Class 3	KOS

Regulation Number	Device Name	Device Class	Product Code
§872.3480	Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)	Class 3	KON

Regulation Number	Device Name	Device Class	Product Code
§872.3500	Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce	Class 3	KXY

Regulation Number	Device Name	Device Class	Product Code
§872.3540	Pad, Denture, Over The Counter	Class 2	EHR
§872.3540	Cushion, Denture, Over The Counter	Class 2	EHS
§872.3540	Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter	Class 1	NKJ

Regulation Number	Device Name	Device Class	Product Code
§872.3560	Reliner, Denture, Over The Counter	Class 2	EBP

Regulation Number	Device Name	Device Class	Product Code
§872.3570	Over The Counter Denture Repair Kit	Class 2	EBO

Regulation Number	Device Name	Device Class	Product Code
§872.3590	Denture, Plastic, Teeth	Class 2	ELM

Regulation Number	Device Name	Device Class	Product Code
§872.3600	Denture Preformed (Partially Prefabricated Denture)	Class 2	EKO

Regulation Number	Device Name	Device Class	Product Code
§872.3640	Implant, Endosseous, Root-Form	Class 2	DZE

Regulation Number	Device Name	Device Class	Product Code
§872.3645	Implant, Subperiosteal	Class 2	ELE

Regulation Number	Device Name	Device Class	Product Code
§872.3660	Material, Impression	Class 2	ELW

Regulation Number	Device Name	Device Class	Product Code
§872.3690	Material, Tooth Shade, Resin	Class 2	EBF

Regulation Number	Device Name	Device Class	Product Code
§872.3070	Mercury	Class 2	ELY

Regulation Number	Device Name	Device Class	Product Code
§872.3710	Alloy, Metal, Base	Class 2	EJH

Regulation Number	Device Name	Device Class	Product Code
§872.3750	Adhesive, Bracket And Tooth Conditioner, Resin	Class 2	DYH

Regulation Number	Device Name	Device Class	Product Code
§872.3760	Resin, Denture, Relining, Repairing, Rebasing	Class 2	EBI

Regulation Number	Device Name	Device Class	Product Code
§872.3765	Sealant, Pit And Fissure, And Conditioner	Class 2	EBC

Regulation Number	Device Name	Device Class	Product Code
§872.3770	Crown And Bridge, Temporary, Resin	Class 2	EBG

Regulation Number	Device Name	Device Class	Product Code
§872.3820	Resin, Root Canal Filling	Class 2	KIF
§872.3820	Resin, Root Canal Filling Containing Chloroform	Class 3	MMT

Regulation Number	Device Name	Device Class	Product Code
§872.3890	Splint, Endodontic Stabilizing	Class 2	ELS

Regulation Number	Device Name	Device Class	Product Code
§872.3940	Joint, Temporomandibular, Implant	Class 3	LZD

Regulation Number	Device Name	Device Class	Product Code
§872.3950	Glenoid Fossa Prosthesis	Class 3	MPI

Regulation Number	Device Name	Device Class	Product Code
§872.3960	Mandibular Condyle Prosthesis	Class 3	MPL

Regulation Number	Device Name	Device Class	Product Code
§872.3970	Interarticular Disc Prosthesis (Interpositional Implant)	Class 3	MPJ

Regulation Number	Device Name	Device Class	Product Code
§872.4120	Drill, Bone, Powered	Class 2	DZI
§872.4120	Driver, Wire, And Bone Drill, Manual	Class 2	DZJ
§872.4120	Handpiece, Rotary Bone Cutting	Class 2	KMW
§872.4120	Saw, Bone, Ac-Powered	Class 2	DZH

Regulation Number	Device Name	Device Class	Product Code
§872.4200	Handpiece, Air-Powered, Dental	Class 1	EFB
§872.4200	Handpiece, Belt And/Or Gear Driven, Dental	Class 1	EFA
§872.4200	Handpiece, Contra- And Right-Angle Attachment, Dental	Class 1	EGS

Regulation Number	Device Name	Device Class	Product Code
§872.4465	Injector, Jet, Gas-Powered	Class 2	EGQ

Regulation Number	Device Name	Device Class	Product Code
§872.4475	Injector, Jet, Mechanical-Powered	Class 2	EGM

Regulation Number	Device Name	Device Class	Product Code
§872.4600	Lock, Wire, And Ligature, Intraoral	Class 2	DYX

Regulation Number	Device Name	Device Class	Product Code
§872.4760	Plate, Bone	Class 2	JEY

Regulation Number	Device Name	Device Class	Product Code
§872.4840	Scaler, Rotary	Class 2	ELB

Regulation Number	Device Name	Device Class	Product Code
§872.4850	Scaler, Ultrasonic	Class 2	ELC

Regulation Number	Device Name	Device Class	Product Code
§872.4880	Screw, Fixation, Intraosseous	Class 2	DZL

Regulation Number	Device Name	Device Class	Product Code
§872.4920	Unit, Electrosurgical, And Accessories, Dental	Class 2	EKZ

Regulation Number	Device Name	Device Class	Product Code
§872.5470	Bracket, Plastic, Orthodontic	Class 2	DYW

Regulation Number	Device Name	Device Class	Product Code
§872.5550	Ring, Teething, Fluid-Filled	Class 2	KKO

Regulation Number	Device Name	Device Class	Product Code
§872.6080	Airbrush	Class 2	KOJ

Regulation Number	Device Name	Device Class	Product Code
§872.6300	Clamp, Rubber Dam	Class 1	EEF
§872.6300	Dam, Rubber	Class 1	EIE
§872.6300	Forceps, Rubber Dam Clamp	Class 1	EJG
§872.6300	Frame, Rubber Dam	Class 1	EJE

Regulation Number	Device Name	Device Class	Product Code
§872.6640	Unit, Operative Dental	Class 1	EIA

Regulation Number	Device Name	Device Class	Product Code
§872.6660	Powder, Porcelain	Class 2	EIH

Regulation Number	Device Name	Device Class	Product Code
§872.6770	Syringe, Cartridge	Class 2	EJI