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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)
 
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
05/30/2022 Dental/
ENT
4-293 Complete ANSI ADA Standard No. 119-2021 Manual Toothbrushes
12/20/2021 Dental/
ENT
4-284 Complete ISO 10873 Second edition 2021-07 Dentistry - Denture adhesives
12/19/2022 Dental/
ENT
4-296 Complete ISO 9873 Fourth edition 2019-03 Dentistry - Intra-oral mirrors
ANSI ADA Standard No. 191-2020 Intra-Oral Mirrors
12/19/2022 Dental/
ENT
4-297 Complete ISO 20126 Third edition 2022-03 Dentistry - Manual toothbrushes - General requirements and test methods
12/20/2021 Dental/
ENT
4-288 Complete ISO 7488 Second edition 2018-04 Dentistry - Mixing machines for dental amalgam
ANSI ADA Standard No. 43-2020 Electrically Powered Dental Amalgamators
12/20/2021 Dental/
ENT
4-289 Complete ISO 18556 Frist edition 2016-04 Dentistry - Intraoral spatulas
12/20/2021 Dental/
ENT
4-290 Complete ISO 28158 Second edition 2018-09 Dentistry - Integrated dental floss and handles
ANSI ADA Standard No. 185-2020 Integrated Dental Floss and Handles
12/20/2021 Dental/
ENT
4-286 Complete ANSI ADA Standard No. 87-1995 (R2014) Dental Impression Trays
12/21/2020 Dental/
ENT
4-269 Complete ISO 3964 Third edition 11-2016 Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
05/29/2023 Dental/
ENT
4-298 Complete ISO 4049 Fifth edition 2019-05 Dentistry - Polymer-based restorative materials
ANSI ADA Standard No. 27-2022 Polymer-based Restorative Materials
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
05/29/2023 Dental/
ENT
4-301 Complete ISO 21563 Second edition 2021-08 Dentistry - Hydrocolloid impression materials
ANSI ADA Standard No. 128-2022 Hydrocolloid Impression Materials
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
05/29/2023 Dental/
ENT
4-302 Complete ISO 10477 Fourth edition 2020-10 Dentistry - Polymer-based crown and veneering materials
ANSI ADA Standard No. 53-2022 Polymer-Based Crown and Veneering Materials
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
12/18/2023 Dental/
ENT
4-315 Complete ISO 24234 Third edition 2021-08 Dentistry - Dental Amalgam
08/06/2013 Dental/
ENT
4-167 Complete ANSI ASA S3.21-2004 (Reaffirmed 2019) American National Standard Methods for Manual Pure-Tone Threshold Audiometry
05/29/2023 Dental/
ENT
4-299 Complete ISO 3107 Fifth edition 2022-09 Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements
ANSI ADA Standard No. 30-2023 Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide Cements
01/30/2014 Dental/
ENT
4-198 Complete ISO 3107 Fourth edition 2011-03-01 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements
ANSI ADA Standard No. 30-2013 (R2018) Dental Zinc Oxide-Eugenol and Zinc Oxide
01/30/2014 Dental/
ENT
4-181 Complete ISO 4049 Fourth edition 2009-10-01 Dentistry - Polymer-based restorative materials
04/04/2016 Dental/
ENT
4-224 Complete ISO 24234 Second edition 2015-05-01 Dentistry - Dental Amalgam
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
09/17/2018 Dental/
ENT
4-244 Complete ISO 8325 Second edition 2004-09-15 Dentistry - Test methods for rotary instruments
12/18/2023 Dental/
ENT
4-318 Complete ISO 20749 Second edition 2023-06 Dentistry - Pre-capsulated dental amalgam
09/17/2018 Dental/
ENT
4-246 Complete ISO 20749 First edition 2017-03 Dentistry - Pre-capsulated dental amalgam
ANSI ADA Standard No. 144-2018 Alloy for Dental Amalgam
12/18/2023 Dental/
ENT
4-316 Complete ISO 20127 Second edition 2020-08 Dentistry - Physical properties of powered toothbrushes
ANSI ADA Standard No.120-2022 Dentistry - Physical Properties of Powered Toothbrushes
12/18/2023 Dental/
ENT
4-317 Complete ISO 8325 Third edition 2023-03 Dentistry - Test methods for rotary instruments
12/20/2021 Dental/
ENT
4-292 Complete ISO 28888 First edition 2013-10 Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
ANSI ADA Standard No. 151-2015 (R2020) Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
12/18/2023 Dental/
ENT
4-321 Complete ISO 23450 First edition 2021-03 Dentistry - Intraoral camera
12/18/2023 Dental/
ENT
4-322 Complete ISO 18675 First edition 2022-05 Dentistry - Machinable ceramic blanks
12/18/2023 Dental/
ENT
4-323 Complete ISO 5139 First edition 2023-05 Dentistry - Polymer-based composite machinable blanks
12/18/2023 Dental/
ENT
4-324 Complete ISO TS 16506 First edition 2018-03 Dentistry - Polymer-based luting materials containing adhesive components
12/18/2023 Dental/
ENT
4-314 Complete ISO 7494-2 Third edition 2022-07 Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems
06/27/2016 Dental/
ENT
4-202 Complete ANSI ADA Standard No. 58-2010 (R2015) Root Canal Files, Type H (Hedstrom)
03/16/2012 Dental/
ENT
4-173 Complete ANSI ASA S3.44-1996 (Reaffirmed 2006) American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
01/30/2014 Dental/
ENT
4-199 Complete ISO 6876 Third edition 2012-06-01 Dentistry -- Root canal sealing materials
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
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
4-222 Complete ISO 6874 Third edition 2015-09-01 Dentistry - Polymer-based pit and fissure sealants
06/07/2018 Dental/
ENT
4-241 Complete ISO 7491 Second edition 2000-09-01 Dental materials - Determination of colour stability
ANSI ADA Standard No. 80-2001 (R2020) Dental Materials-Determination of Color Stability
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
01/14/2019 Dental/
ENT
4-171 Complete ANSI ASA S3.37-1987 (Reaffirmed 2020) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
01/30/2014 Dental/
ENT
4-153 Complete ISO 9917-1 Second edition 2007-10-01 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
01/30/2014 Dental/
ENT
4-180 Complete ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces
06/27/2016 Dental/
ENT
4-228 Complete ANSI ASA S3.20-2015 (Reaffirmed 2020) American National Standard Bioacoustical Terminology
07/09/2014 Dental/
ENT
4-177 Complete ANSI ASA S12.65-2006 (Reaffirmed 2020) American National Standard For Rating Noise with Respect to Speech Interference
04/04/2016 Dental/
ENT
4-190 Complete ANSI ASA S3.35-2010 (Reaffirmed 2020) American National Standard Method for Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions
08/06/2013 Dental/
ENT
4-204 Complete ANSI ASA S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020) American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
08/06/2013 Dental/
ENT
4-90 Complete ANSI ASA S3.39:1987 (Reaffirmed 2020) American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
08/21/2017 Dental/
ENT
4-233 Complete ISO 20795-2 Second edition 2013-03-01 Dentistry - Base polymers - Part 2: Orthodontic base polymers
08/14/2015 Dental/
ENT
4-130 Complete ANSI ADA Standard No. 17-1983 (R2014) Denture Base Temporary Relining Resins
12/18/2023 Dental/
ENT
4-320 Complete ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
07/09/2014 Dental/
ENT
4-165 Complete ANSI ASA S3.13-1987 (Reaffirmed 2020) American National Standard Mechanical Coupler for Measurement of Bone Vibrators
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
12/21/2020 Dental/
ENT
4-268 Complete ISO 15841 Second edition 2014-08 Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)]
ANSI ADA Standard No. 32-2017 Orthodontic Wires
12/20/2021 Dental/
ENT
4-291 Complete ISO 28399 First edition 2011-01 Dentistry - Products for external tooth bleaching
ANSI ADA Standard No. 136-2015 (R2020) Products for External Tooth Bleaching
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
07/09/2014 Dental/
ENT
4-149 Complete ANSI ADA Standard No. 39-2006 (R2011) Pit and Fissure Sealants
07/09/2014 Dental/
ENT
4-160 Complete ANSI ASA S3.1-1999 (Reaffirmed 2023) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
08/14/2015 Dental/
ENT
4-220 Complete ANSI ASA S3.22-2014 (Reaffirmed 2020) American National Standard Specification of Hearing Aid Characteristics
07/09/2014 Dental/
ENT
4-97 Complete ANSI ADA Standard No. 57-2000 (R2012) Endodontic Sealing Material
08/21/2017 Dental/
ENT
4-215 Complete ANSI ADA Standard No. 96-2012 Dental Water-based Cements
09/17/2018 Dental/
ENT
4-242 Complete ISO 10139-1 Third edition 2018-03 Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
ANSI ADA Standard No. 75-2020 Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials
09/17/2018 Dental/
ENT
4-247 Complete ISO 28319 Second edition 2018-04 Dentistry - Laser welding and filler materials
ANSI ADA Standard No. 84-2020 Laser Welding and Filler Materials in Dentistry
01/30/2014 Dental/
ENT
4-137 Complete ISO 6877 Second edition 2006-04-01 Dentistry - Root-canal obturating points
ANSI ADA Standard No. 78-2013 Dental obturating cones
12/18/2023 Dental/
ENT
4-310 Complete ISO 22112 Second edition 2017-08 Dentistry - Artificial teeth for dental prostheses
ANSI ADA Standard No. 15-2021 Artificial Teeth for Dental Prostheses
01/30/2014 Dental/
ENT
4-151 Complete ISO 22112 First edition 2005-11-01 Dentistry - Artificial teeth for dental prostheses
ANSI ADA Standard No. 15-2008 (R2013) Artificial Teeth for Dental Prostheses
01/30/2014 Dental/
ENT
4-188 Complete ISO 9917-2 Second edition 2010-04-15 Dentistry - Water-based cements - Part 2: Resin-modified cements
12/18/2023 Dental/
ENT
4-313 Complete ISO 27020 Second edition 2019-06 Dentistry - Brackets and tubes for use in orthodontics
ANSI ADA Standard No.100-2020 Orthodontic Brackets and Tubes
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
12/21/2020 Dental/
ENT
4-265 Complete ISO 10271 Third edition 2020-08 Dentistry - Corrosion test methods for metallic materials
ANSI ADA Standard No. 97-2020 Corrosion Test Methods for Metallic Materials
01/27/2015 Dental/
ENT
4-185 Complete ANSI ASA S3.45-2009 (Reaffirmed 2019) American National Standard Procedures for Testing Basic Vestibular Function
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
08/21/2017 Dental/
ENT
4-232 Complete ISO 20795-1 Second edition 2013-03-01 Dentistry - Base polymers - Part 1: Denture base polymers
12/18/2023 Dental/
ENT
4-311 Complete ISO 9917-2 Third edition 2017-09 Dentistry - Water-based cements - Part 2: Resin-modified cements
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
05/29/2023 Dental/
ENT
4-304 Complete ISO 21606 Second edition 2022-08 Dentistry - Elastomeric auxiliaries for use in orthodontics
12/21/2020 Dental/
ENT
4-267 Complete ISO 21606 First edition 2007-06 Dentistry - Elastomeric auxiliaries for use in orthodontics
ANSI ADA Standard No. 105-2010 (R2015) Orthodontic Elastomeric Materials
12/18/2023 Dental/
ENT
4-309 Complete ISO 6877 Third edition 2021-09 Dentistry - Endodontic obturating materials
ANSI ADA Standard No. 78-2021 Dentistry - Endodontic Obturating Materials
08/21/2017 Dental/
ENT
4-239 Complete ANSI AAMI CI86:2017 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
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
12/21/2020 Dental/
ENT
4-270 Complete ANSI ADA Technical Report No. 146-2018 CAD/CAM Abutments in Dentistry
05/29/2023 Dental/
ENT
4-300 Complete ISO 22674 Third edition 2022-08 Dentistry - Metallic materials for fixed and removable restorations and appliances
01/14/2019 Dental/
ENT
4-163 Complete ANSI ASA S3.5-1997 (Reaffirmed 2020) American National Standard Methods for Calculation of the Speech Intelligibility Index
09/09/2008 Dental/
ENT
4-145 Complete ISO 22803 First edition 2004-09-01 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
12/21/2020 Dental/
ENT
4-266 Complete ISO 19023 First edition 2018-02 Dentistry - Orthodontic anchor screws
ANSI ADA Standard No. 178-2019 Orthodontic Anchor Screws
05/29/2023 Dental/
ENT
4-303 Complete ISO 9333 Third edition 2022-08 Dentistry - Brazing materials
12/23/2019 Dental/
ENT
4-262 Complete IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
01/14/2019 Dental/
ENT
4-255 Complete ANSI ADA Standard No. 131-2015 (R2020) Dental CAD/CAM Machinable Zirconia Blanks
01/14/2019 Dental/
ENT
4-162 Complete ANSI ASA S3.4-2007 (Reaffirmed 2020) American National Standard Procedure for the Computation of Loudness of Steady Sounds
01/14/2019 Dental/
ENT
4-250 Complete ISO 7494-1 Third edition 2018-06 Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
01/14/2019 Dental/
ENT
4-251 Complete ISO 6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04] Dentistry - Ceramic materials
ANSI ADA Standard No. 69-2020 Dental Ceramic
12/23/2019 Dental/
ENT
4-260 Complete ANSI ASA S12.2-2019 American National Standard for Criteria for Evaluating Room Noise
07/15/2019 Dental/
ENT
4-258 Complete ISO 10139-2 Third edition 2016-06-15 Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
ANSI ADA Standard No. 160-2020 Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use
12/23/2019 Dental/
ENT
4-261 Complete ISO 7405 Third edition 2018-10 Corrected version 2018-12 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
06/07/2021 Dental/
ENT
4-279 Complete ANSI ADA Standard No. 85-2004 (R2009) Part 1: Disposable Prophy Angles
 
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