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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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12/21/2020 Dental/
ENT
4-269 Complete ISO 3964 Third edition 11-2016 Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
06/07/2021 Dental/
ENT
4-273 Complete ANSI ASA S3.7-2016 (Reaffirmed 2023) American National Standard Method for Coupler Calibration of Earphones
06/07/2021 Dental/
ENT
4-275 Complete ANSI ASA S3.6-2018 American National Standard for Specification for Audiometers
06/07/2021 Dental/
ENT
4-276 Partial ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors
ANSI ADA Standard No. 35-2019 Dental Handpieces and Motors
06/07/2021 Dental/
ENT
4-280 Partial ANSI ADA Standard No. 117-2018 Fluoride varnishes
06/07/2021 Dental/
ENT
4-281 Complete ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments
ANSI ADA Standard No. 179-2020 Shanks for Rotary and Oscillating Instruments
12/20/2021 Dental/
ENT
4-284 Complete ISO 10873 Second edition 2021-07 Dentistry - Denture adhesives
12/20/2021 Dental/
ENT
4-285 Complete ANSI ADA Standard No. 37-1986 (R2020) Dental Abrasive Powders
12/20/2021 Dental/
ENT
4-286 Complete ANSI ADA Standard No. 87-1995 (R2014) Dental Impression Trays
12/20/2021 Dental/
ENT
4-287 Complete ANSI ADA Standard No. 116-2020 Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)
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