Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

059

Date of Entry 12/19/2022

FR Recognition Number

4-295

Standard

ANSI ADA Standard No. 41-2020
Evaluation of Biocompatibility of Medical Devices Used in Dentistry

Scope/Abstract

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

Michael Adjodha

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6276

michael.adjodha@fda.hhs.gov

Sherrill Lathrop Blitzer

FDA/OC/CDRH/OPEQ/OHTI/DHTIB/

301-796-6375

Sherrill.Blitzer@FDA.HHS.GOV

Standards Development Organizations