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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 059 Date of Entry 12/19/2022 
FR Recognition Number 4-295
ANSI ADA  Standard No. 41-2020
Evaluation of Biocompatibility of Medical Devices Used in Dentistry
This standard 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.

This standard is a modified adoption of ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3060 Alloy, Other Noble Metal Class 2 EJS
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3070 Alloy, Amalgam Class 2 EJJ
§872.3070 Mercury Class 2 ELY
§872.3070 Dental Amalgam Class 2 OIV
§872.3275 Cement, Dental Class 2 EMA
§872.3275 Zinc Oxide Eugenol Class 1 EMB
§872.3275 Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief Class 2 MZW
§872.3300 Coating, Denture Hydrophilic, Resin Class 2 EBE
§872.3310 Coating, Filling Material, Resin Class 2 EBD
§872.3330 Crown, Preformed Class 1 ELZ
§872.3660 Material, Impression Class 2 ELW
§872.3690 Material, Tooth Shade, Resin Class 2 EBF
§872.3710 Alloy, Metal, Base Class 2 EJH
§872.3750 Adhesive, Bracket And Tooth Conditioner, Resin Class 2 DYH
§872.3750 Solution, Cement Dissolving Class 2 KZP
§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, Long-Term Temporary, Resin Class 2 POW
§872.3820 Resin, Root Canal Filling Class 2 KIF
§872.3920 Teeth, Porcelain Class 2 ELL
§872.5470 Bracket, Plastic, Orthodontic Class 2 DYW
§872.5470 Bracket, Ceramic, Orthodontic Class 2 NJM
§872.5470 Aligner, Sequential Class 2 NXC
§872.5525 Positioner, Tooth, Preformed Class 1 KMY
§872.5550 Ring, Teething, Fluid-Filled Class 2 KKO
§872.5550 Ring, Teething, Non-Fluid Filled Class 1 MEF
§872.5570 Device, Jaw Repositioning Class 2 LQZ
§872.5570 Device, Anti-Snoring Class 2 LRK
§872.5570 Pillow, Cervical (For Mild Sleep Apnea) Class 2 MYB
§872.5570 Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea Class 2 OHP
§872.5570 Tongue Suspension System Class 2 ORY
§872.5570 Intraoral Pressure Gradient Device Class 2 OZR
§872.5570 Sleep Appliances With Patient Monitoring Class 2 PLC
§872.5571 Closed Loop Auto Titration Device For Oral Appliances Class 2 QCJ
872.5575 Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea Class 2 QNO
§872.5580 Rinse, Oral, Antibacterial (By Physical Means) Class 2 NTO
§872.6030 Agent, Polishing, Abrasive, Oral Cavity Class 1 EJR
§872.6660 Powder, Porcelain Class 2 EIH
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 Document, issued September, 2020.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Sherrill Lathrop Blitzer
 Michael Adjodha
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
ADA American Dental Association http://www.ada.org
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.