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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Standard Title
(click for recognition information)
 
07/09/2014 Dental/
ENT
4-211 Complete ANSI ASA S3.46-2013 (Reaffirmed 2023) American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
08/21/2017 Dental/
ENT
4-215 Complete ANSI ADA Standard No. 96-2012 Dental Water-based Cements
01/14/2019 Dental/
ENT
4-217 Complete ANSI ASA S3.36-2012 (Reaffirmed 2022) American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
01/27/2015 Dental/
ENT
4-218 Complete ISO 27020 First edition 2010-12-15 Dentistry - Brackets and tubes for use in orthodontics
ANSI ADA Standard No.100-2012 Orthodontic Brackets and Tubes
01/27/2015 Dental/
ENT
4-219 Complete ISO 29022 First edition 2013-06-01 Dentistry - Adhesive - Notched-edge sheer bond strength test
08/14/2015 Dental/
ENT
4-220 Complete ANSI ASA S3.22-2014 (Reaffirmed 2020) American National Standard Specification of Hearing Aid Characteristics
04/04/2016 Dental/
ENT
4-221 Complete ISO 7494-2 Second edition 2015-04-01 Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
04/04/2016 Dental/
ENT
4-222 Complete ISO 6874 Third edition 2015-09-01 Dentistry - Polymer-based pit and fissure sealants
04/04/2016 Dental/
ENT
4-224 Complete ISO 24234 Second edition 2015-05-01 Dentistry - Dental Amalgam
06/27/2016 Dental/
ENT
4-227 Complete ISO 22674 Second edition 2016-01-15 Dentistry - Metallic materials for fixed and removable restorations and appliances
ANSI ADA Standard No. 134-2018 Metallic Materials for Fixed and Removable Restorations and Appliances
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