Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

066

Date of Entry 05/25/2026

FR Recognition Number

4-399

Standard

ISO TS 19736 First edition 2017-09
Dentistry - Bonding test between polymer teeth and denture base materials

Identical Adoption

ANSI ADA Standard No. 182-2021
Test Method for the Bonding Test Between Polymer Teeth and Denture Base Polymer

Scope/Abstract

ISO/TS 19736:2017 specifies a test method for bonding of polymer teeth to denture base materials.

This test method is not designed to prove the properties of polymer teeth and denture base materials.

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
§872.3560	Reliner, Denture, Over The Counter	Class 2	EBP
§872.3590	Additively Manufactured, Preformed, Resin Denture Tooth	Class 2	PZY
§872.3690	Material, Tooth Shade, Resin	Class 2	EBF
§872.3760	Resin, Denture, Relining, Repairing, Rebasing	Class 2	EBI

Relevant FDA Guidance and/or Supportive Publications*

Guidance for Industry and FDA Staff: OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits, issued August 1998.

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

Joel Anderson

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

301-796-6520

Joel.Anderson@fda.hhs.gov

Ran Huo

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

240-402-6705

Ran.Huo@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization