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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Standard Title
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12/18/2023 Dental/
ENT		 4-321 Complete ISO 23450 First edition 2021-03 Dentistry - Intraoral camera
01/27/2015 Dental/
ENT		 4-136 Complete ASTM F2504-05 (Reapproved 2022) Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
12/18/2023 Dental/
ENT		 4-312 Complete ANSI ASA S3.35-2021 American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions
05/29/2023 Dental/
ENT		 4-307 Complete ISO 13504 First edition 2012-07 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
05/29/2023 Dental/
ENT		 4-308 Complete ISO 14708-7 Second edition 2019-12 Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems
01/14/2019 Dental/
ENT		 4-248 Complete ISO 10477 Third edition 2018-06 Dentistry - Polymer-based crown and veneering materials
05/29/2023 Dental/
ENT		 4-303 Complete ISO 9333 Third edition 2022-08 Dentistry - Brazing materials
12/21/2020 Dental/
ENT		 4-264 Complete ISO 9333 Second edition 2006-07 Dentistry - Brazing materials
ANSI ADA Standard No. 88-2019 Dental Brazing Alloys
05/29/2024 Dental/
ENT		 4-325 Complete ANSI ADA Standard No. 96-2020 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
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