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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 4-261
Standard
ISO 7405 Third edition 2018-10 Corrected version 2018-12 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
Scope/Abstract
This document specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.

This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 7405 Second edition 2008-12-15 [Rec# 4-212] will be superseded by recognition of ISO 7405 Third edition 2018-10 Corrected version 2018-12 [Rec# 4-261]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-212] until December 27, 2020. After this transition period, declarations of conformity to [Rec# 4-212] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§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
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
§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 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
§872.3765 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
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 Dissolving 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
Relevant FDA Guidance and/or Supportive Publications*
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff, issued June 2016.
FDA Technical Contacts
 Sherrill Lathrop Blitzer
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6375
  Sherrill.Blitzer@FDA.HHS.GOV
 Mehdi Kazemzadeh-Narbat
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-7451
  Mehdi.Kazemzadeh-Narbat@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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