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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)
 
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
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
08/21/2017 Dental/
ENT		 4-238 Complete ISO 20127 First edition 2005-03-15 Dentistry - Powered toothbrushes - General requirements and test methods
ANSI ADA Standard No.120-2009 (R2014) Powered Toothbrushes
06/07/2018 Dental/
ENT		 4-240 Complete ISO 21563 First edition 2013-08-15 Dentistry - Hydrocolloid impression materials
ANSI ADA Standard No. 128-2015 Hydrocolloid Impression Materials
09/17/2018 Dental/
ENT		 4-244 Complete ISO 8325 Second edition 2004-09-15 Dentistry - Test methods for rotary instruments
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