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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 036 FR Publication Date: 07/09/2014 

Part B: Supplementary Information

Recognition Number 4-212: ISO 7405 Second edition 2008-12-15, dentistry - evaluation of biocompatibility of medical devices used in dentistry [including: amendment 1 (2013)]. (Dental/ENT)

Date of Standard: 2008. 
Address of Standards Development 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
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Device, Electrical Dental Anesthesia   LWM
Unclassified Laser, Dental   LYB
Unclassified Locator, Root Apex   LQY
Unclassified Saliva, Artificial   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
§872.1720 Tester, Pulp Class 2 EAT
§872.1740 Device, Caries Detection Class 2 LFC
§872.3070 Alloy, Amalgam Class 2 EJJ
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3060 Alloy, Other Noble Metal Class 2 EJS
§872.3200 Agent, Tooth Bonding, Resin Class 2 KLE
§872.3250 Liner, Cavity, Calcium Hydroxide Class 2 EJK
§872.3260 Varnish, Cavity Class 2 LBH
§872.3275 Cement, Dental Class 2 EMA
§872.3300 Coating, Denture Hydrophilic, Resin Class 2 EBE
§872.3310 Coating, Filling Material, Resin Class 2 EBD
§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
§872.3420 Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer Class 3 KOS
§872.3480 Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic) Class 3 KON
§872.3500 Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce Class 3 KXY
§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
§872.3560 Reliner, Denture, Over The Counter Class 2 EBP
§872.3570 Over The Counter Denture Repair Kit Class 2 EBO
§872.3590 Denture, Plastic, Teeth Class 2 ELM
§872.3600 Denture Preformed (Partially Prefabricated Denture) Class 2 EKO
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
§872.3645 Implant, Subperiosteal Class 2 ELE
§872.3660 Material, Impression Class 2 ELW
§872.3690 Material, Tooth Shade, Resin Class 2 EBF
§872.3070 Mercury Class 2 ELY
§872.3710 Alloy, Metal, Base Class 2 EJH
§872.3750 Adhesive, Bracket And Tooth Conditioner, Resin Class 2 DYH
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
§872.3765 Sealant, Pit And Fissure, And Conditioner Class 2 EBC
§872.3770 Crown And Bridge, Temporary, Resin Class 2 EBG
§872.3820 Resin, Root Canal Filling Class 2 KIF
§872.3820 Resin, Root Canal Filling Containing Chloroform Class 3 MMT
§872.3890 Splint, Endodontic Stabilizing Class 2 ELS
§872.3940 Joint, Temporomandibular, Implant Class 3 LZD
§872.3950 Glenoid Fossa Prosthesis Class 3 MPI
§872.3960 Mandibular Condyle Prosthesis Class 3 MPL
§872.3970 Interarticular Disc Prosthesis (Interpositional Implant) Class 3 MPJ
§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
§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
§872.4465 Injector, Jet, Gas-Powered Class 2 EGQ
§872.4475 Injector, Jet, Mechanical-Powered Class 2 EGM
§872.4600 Lock, Wire, And Ligature, Intraoral Class 2 DYX
§872.4760 Plate, Bone Class 2 JEY
§872.4840 Scaler, Rotary Class 2 ELB
§872.4850 Scaler, Ultrasonic Class 2 ELC
§872.4880 Screw, Fixation, Intraosseous Class 2 DZL
§872.4920 Unit, Electrosurgical, And Accessories, Dental Class 2 EKZ
§872.5470 Bracket, Plastic, Orthodontic Class 2 DYW
§872.5550 Ring, Teething, Fluid-Filled Class 2 KKO
§872.6080 Airbrush Class 2 KOJ
§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
§872.6640 Unit, Operative Dental Class 1 EIA
§872.6660 Powder, Porcelain Class 2 EIH
§872.6770 Syringe, Cartridge Class 2 EJI
FDA Technical Contact:
 Andrew Steen
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2604
  Silver Spring MD 20993
  301/796-6284
  email: andrew.steen@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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