Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

038

Date of Entry 01/27/2015

FR Recognition Number

4-219

Standard

ISO 29022 First edition 2013-06-01
Dentistry - Adhesive - Notched-edge sheer bond strength test

Scope/Abstract

This International Standard specifies a shear test method used to determine the adhesive bond strength between direct dental restorative materials and tooth structure, e.g. dentine or enamel. The method as described is principally intended for dental adhesives. The method includes substrate selection, storage and handling of tooth structure, as well as the procedure for testing.

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
§872.3200	Agent, Tooth Bonding, Resin	Class 2	KLE
§872.3275	Cement, Dental	Class 2	EMA
§872.3275	Zinc Oxide Eugenol	Class 1	EMB
§872.3690	Material, Tooth Shade, Resin	Class 2	EBF
§872.3750	Adhesive, Bracket And Tooth Conditioner, Resin	Class 2	DYH

Relevant FDA Guidance and/or Supportive Publications*

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

Sheena Green

FDA/OC/CDRH/OPEQ/OCEA/DCEAI/

301-796-6279

sheena.green@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization