Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

052

Date of Entry 07/15/2019

FR Recognition Number

4-258

Standard

ISO 10139-2 Third edition 2016-06-15
Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use

Identical Adoption

ANSI ADA Standard No. 160-2020
Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use

Scope/Abstract

This part of ISO 10139 specifies requirements for softness, adhesion, water sorption and water solubility, as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses.

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
§872.3760	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

Michael Adjodha

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

301-796-6276

michael.adjodha@fda.hhs.gov

Joel Anderson

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

301-796-6520

joel.anderson@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization