Recognized Consensus Standards: Medical Devices
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Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 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) |
| 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 |
4-291 | 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 | ||||
| 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 | ||||
| 05/30/2022 | Dental/ ENT |
4-293 | Complete | ANSI ADA | Standard No. 119-2021 | Manual Toothbrushes |
| 12/19/2022 | Dental/ ENT |
4-294 | Complete | ANSI ADA | Standard No. 139-2020 | Dental Base Polymers |
| 12/19/2022 | Dental/ ENT |
4-295 | Complete | ANSI ADA | Standard No. 41-2020 | Evaluation of Biocompatibility of Medical Devices Used in Dentistry |
| 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 |
| 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 | ||||
| 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 | ||||
| 05/29/2023 | Dental/ ENT |
4-300 | Complete | ISO | 22674 Third edition 2022-08 | Dentistry - Metallic materials for fixed and removable restorations and appliances |
| ANSI ADA | Standard No. 134-2023 | Dentistry - 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 | ||||
| 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 | ||||
| 05/29/2023 | Dental/ ENT |
4-303 | Complete | ISO | 9333 Third edition 2022-08 | Dentistry - Brazing materials |
| 05/29/2023 | Dental/ ENT |
4-304 | Complete | ISO | 21606 Second edition 2022-08 | Dentistry - Elastomeric auxiliaries for use in orthodontics |
| 05/29/2023 | Dental/ ENT |
4-305 | Partial | ISO | 10637 Second edition 2018-05 | Dentistry - Central suction source equipment |
| ANSI ADA | Standard No. 177-2020 | Central Suction Source Equipment | ||||
| 05/29/2023 | Dental/ ENT |
4-306 | Partial | ISO | 22052 First edition 2020-06 | Dentistry - Compressed air source equipment |
| ANSI ADA | Standard No. 94-2021 | Central Compressed Air Source Equipment | ||||
| 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 |
| 12/18/2023 | Dental/ ENT |
4-309 | Complete | ISO | 6877 Third edition 2021-09 | Dentistry - Endodontic obturating materials |
| ANSI ADA | Standard No. 78-2022 | Dentistry - Endodontic Obturating Materials | ||||
| 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 | ||||
| 12/18/2023 | Dental/ ENT |
4-311 | Complete | ISO | 9917-2 Third edition 2017-09 | Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 12/18/2023 | 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 |
| 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 | ||||
| 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 |
| 12/18/2023 | Dental/ ENT |
4-315 | Complete | ISO | 24234 Third edition 2021-08 | Dentistry - 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 |
| 12/18/2023 | Dental/ ENT |
4-318 | Complete | ISO | 20749 Second edition 2023-06 | Dentistry - Pre-capsulated dental amalgam |
| 12/18/2023 | Dental/ ENT |
4-319 | Partial | ISO | 17730 Second edition 2020-09 | Dentistry - Fluoride varnishes |
| ANSI ADA | Standard No. 117-2022 | Dentistry - Fluoride Varnishes | ||||
| 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 |
| 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 2017-07 Corrected version 2018-03 | Dentistry - Polymer-based luting materials containing adhesive components |
| 05/29/2024 | Dental/ ENT |
4-325 | Complete | ANSI ADA | Standard No. 96-2020 | Dental Water-based Cements |
| 05/29/2024 | Dental/ ENT |
4-326 | Complete | ISO | 9687 Second edition 2015-02 | Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)] |
| 05/29/2024 | Dental/ ENT |
4-327 | Complete | ISO | 21531 First edition 2009-02 | Dentistry - Graphical symbols for dental instruments |
| 12/23/2024 | Dental/ ENT |
4-328 | Complete | ANSI ADA | Standard No. 57-2021 | Endodontic Sealing Materials |
| 12/23/2024 | Dental/ ENT |
4-329 | Complete | ISO | 6872 Fifth edition 2024-08 | Dentistry - Ceramic materials |
| 12/23/2024 | Dental/ ENT |
4-330 | Complete | ANSI ADA | Standard No. 63-2020 | Endodontic Instruments - Auxillary |
| 12/23/2024 | Dental/ ENT |
4-331 | Complete | ISO | 28399 Third edition 2021-03 | Dentistry - External tooth bleaching products |
| ANSI ADA | Standard No. 136-2022 | Dentistry - External Tooth Bleaching Products | ||||
| 12/23/2024 | Dental/ ENT |
4-332 | Complete | ANSI ADA | Standard No. 206-2024 | Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File |
| 12/23/2024 | Dental/ ENT |
4-333 | Complete | ISO | 3630-4 Second edition 2023-08 | Dentistry - Endodontic instruments - Part 4: Auxiliary instruments |
| 12/23/2024 | Dental/ ENT |
4-334 | Complete | ISO | 11143 Second edition 2008-07 | Dentistry - Amalgam separators |
| ANSI ADA | Standard No. 108-2009, Addendum (R2022) | Amalgam Separators | ||||
| 12/23/2024 | Dental/ ENT |
4-335 | Complete | ISO | 11499 Third edition 2014-06 | Dentistry - Single-use cartridges for local anaesthetics |
| ANSI ADA | Standard No. 190-2020 | Single-Use Dental Cartridges for Local Anesthetics | ||||
| 12/23/2024 | Dental/ ENT |
4-336 | Complete | ISO | 18397 First edition 2016-01 | Dentistry - Powered scaler |
| ANSI ADA | Standard No. 157-2020 | Powered Dental Scaler Handpieces and Tips | ||||
| 12/23/2024 | Dental/ ENT |
4-337 | Complete | ISO | 20608 First edition 2018-04 | Dentistry - Powder jet handpieces and powders |
| 12/23/2024 | Dental/ ENT |
4-338 | Complete | ISO | 22683 First edition 2022-05 | Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems |
| 05/26/2025 | Dental/ ENT |
4-339 | Complete | ANSI ADA | Standard No. 119-2023 | Dentistry-Manual Toothbrushes |
| 05/26/2025 | Dental/ ENT |
4-340 | Complete | ANSI ADA | Standard No. 46-2016 | Dental Patient Chair |
| 05/26/2025 | Dental/ ENT |
4-341 | Complete | ANSI ADA | Standard No. 47-1-2021 | Stationary Dental Units and Patient Chairs-Part 1: General Requirements |
| 05/26/2025 | Dental/ ENT |
4-342 | Complete | ANSI ADA | Standard No. 47-2-2021 | Stationary Dental Units and Patient Chairs-Part 2: Air, Water, Suction and Wastewater Systems |
| 05/26/2025 | Dental/ ENT |
4-343 | Complete | ANSI ADA | Standard No. 105-2024 | Elastomeric Auxiliaries for Use in Orthodontics |
| 05/26/2025 | Dental/ ENT |
4-344 | Complete | ANSI ADA | Standard No. 186-2024 | Dentistry - Polymer-based Machinable Blanks |
| 05/26/2025 | Dental/ ENT |
4-345 | Complete | ANSI ADA | Standard No. 187-2024 | Dentistry - Dental CAD/CAM Machinable Ceramic Blanks |
| 05/26/2025 | Dental/ ENT |
4-346 | Complete | ISO | 9680 Fourth edition 2021-11 | Dentistry - Operating lights |
| ANSI ADA | Standard No. 89-2023 | Dentistry - Dental Operating Lights | ||||
| 05/26/2025 | Dental/ ENT |
4-347 | Complete | ISO | 22254 First edition 2005-08 | Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection |
| 12/22/2025 | Dental/ ENT |
4-348 | Complete | ISO | 9917-1 Third Edition 2025-05 | Dentistry - Water-based cements - Part 1: Acid-base cements |
| 12/22/2025 | Dental/ ENT |
4-349 | Complete | ANSI ADA | Standard No. 34-2025 | Dental Cartridge Syringes |
| 12/22/2025 | Dental/ ENT |
4-350 | Complete | ANSI ASA | S3.6-2025 | American National Standard Specification for Audiometers |
| 12/22/2025 | Dental/ ENT |
4-351 | Complete | ISO | 6877 Fourth edition 2025-08 | Dentistry - Endodontic obturating materials |
| 12/22/2025 | Dental/ ENT |
4-352 | Complete | ANSI ASA | S3.35-2025 | American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions |
| 12/22/2025 | Dental/ ENT |
4-353 | Complete | ISO | 20127 Third edition 2025-05 | Dentistry - Physical properties of powered toothbrushes |
| 12/22/2025 | Dental/ ENT |
4-354 | Partial | ISO | 17730 Third edition 2025-09 | Dentistry - Fluoride varnishes |
| ANSI ADA | Standard No. 117-2022 | Dentistry - Fluoride Varnishes | ||||
| 12/22/2025 | Dental/ ENT |
4-355 | Complete | ISO | 18397 Second edition 2025-07 | Dentistry - Powered scaler |
| 12/22/2025 | Dental/ ENT |
4-356 | Complete | ANSI ADA | Standard No. 32-2024 | Dentistry - Orthodontic Wires |
| 12/22/2025 | Dental/ ENT |
4-357 | Complete | ANSI ADA | Standard No. 54-1986 (R2024) | Double-Pointed, Parenteral, Single Use Needles for Dentistry |
| 12/22/2025 | Dental/ ENT |
4-358 | Complete | ANSI ADA | Standard No. 95-2020 | Endodontics Instruments - Enlargers |
| 12/22/2025 | Dental/ ENT |
4-359 | Complete | ANSI ADA | Standard No. 159-2024 | Dentistry - Coiled Springs for Use in Orthodontics |
| 12/22/2025 | Dental/ ENT |
4-360 | Complete | ISO | 3630-1 Third edition 2019-08 | Dentistry - Endodontic instruments - Part 1: General requirements |
| ANSI ADA | Standard No. 101-2021 | Endodontic Instruments - General Requirements | ||||
| 12/22/2025 | Dental/ ENT |
4-361 | Complete | ISO | 3630-2 Fourth edition 2023-02 | Dentistry - Endodontic instruments - Part 2: Enlargers |
| 12/22/2025 | Dental/ ENT |
4-362 | Complete | ISO | 3630-3 Third edition 2021-06 Corrected version 2023-05 | Dentistry - Endodontic instruments - Part 3: Compactors |
| ANSI ADA | Standard No. 71-2022 | Dentistry - Endodontic Instruments: Compactors | ||||
| 12/22/2025 | Dental/ ENT |
4-363 | Complete | ISO | 3630-5 Second edition 2020-08 | Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments |
| ANSI ADA | Standard No. 28-2021 | Endodontic Instruments - Shaping and Cleaning Instruments | ||||
| 12/22/2025 | Dental/ ENT |
4-364 | Complete | ISO | 3990 First edition 2023-07 | Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials |
| 12/22/2025 | Dental/ ENT |
4-365 | Complete | ISO | 6873 Third edition 2013-04 | Dentistry - Gypsum products |
| ANSI ADA | Standards No. 25-2015 (R2021) | Dental Gypsum Products | ||||
| 12/22/2025 | Dental/ ENT |
4-366 | Complete | ISO | 7551 Second edition 2023-05 | Dentistry - Endodontic absorbent points |
| ANSI ADA | Standard No. 73-2024 | Dentistry - Endodontic Absorbent Points | ||||
| 12/22/2025 | Dental/ ENT |
4-367 | Complete | ISO | 9997 Third edition 2020-01 | Dentistry - Cartridge Syringes |
| 05/25/2026 | Dental/ ENT |
4-368 | Complete | ISO | 4823 Sixth edition 2025-06 | Dentistry - Elastomeric impression and bite registration materials |
| 05/25/2026 | Dental/ ENT |
4-369 | Complete | ANSI ADA | Standard No. 113-2015 | Periodontal Curettes, Dental Scalers and Excavators |
| 05/25/2026 | Dental/ ENT |
4-370 | Complete | ANSI ADA | Standard No. 126-2015 (R2023) | Casting Investments and Refractory Die Materials |
| 05/25/2026 | Dental/ ENT |
4-371 | Complete | ANSI ADA | Standard No. 135-2015 (R2020) | Denture Adhesives |
| 05/25/2026 | Dental/ ENT |
4-372 | Complete | ANSI ADA | Standard No. 141-2013 (R2023) | Dentistry-Dental Duplicating Material |
| 05/25/2026 | Dental/ ENT |
4-373 | Complete | ANSI ADA | Standard No. 170-2019 | Periodontal Probes - Dental Excavators - Discoid Type: General Requirements |
| 05/25/2026 | Dental/ ENT |
4-374 | Complete | ANSI ADA | Standard No. 195-2021 | Dental Tweezers |
| 05/25/2026 | Dental/ ENT |
4-375 | Complete | ANSI ADA | Standard No. 197-2021 | Spoons and Bone Curettes in Dentistry |
| 05/25/2026 | Dental/ ENT |
4-376 | Complete | ISO | 7492 Fourth edition 2019-03 | Dentistry - Dental explorer |
| 05/25/2026 | Dental/ ENT |
4-377 | Complete | ISO | 9173-1 Third edition 2016-10 | Dentistry - Extraction forceps - Part 1: General requirements |
| 05/25/2026 | Dental/ ENT |
4-378 | Complete | ISO | 9173-2 First edition 2010-05 | Dentistry - Extraction forceps - Part 2: Designation |
| 05/25/2026 | Dental/ ENT |
4-379 | Complete | ISO | 9173-3 First edition 2014-05 | Dentistry - Extraction forceps - Part 3: Design |
| 05/25/2026 | Dental/ ENT |
4-380 | Complete | ISO | 13017 Second edition 2020-07 | Dentistry - Magnetic attachments |
| ANSI ADA | Standard No. 201-2022 | Dentistry - Magnetic Attachments | ||||
| 05/25/2026 | Dental/ ENT |
4-381 | Complete | ISO | 13078 First edition 2013-02 | Dentistry - Dental furnace - Test method for temperature measurement with separate thermocouple |
| ANSI ADA | Standard No.163-2018 | Dental Furnance, Part 1: Test Method for Temperature Measurement with Separate Thermocouple | ||||
| 05/25/2026 | Dental/ ENT |
4-382 | Complete | ISO | 13078-2 First edition 2016-07 | Dentistry - Dental furnace - Part 2: Test method for evaluation of furnace programme via firing glaze |
| ANSI ADA | Standard No. 164-2018 (R2023) | Dental Furnance, Part 2: Test Method for Evaluation of Furnace Program via Firing Glaze | ||||
| 05/25/2026 | Dental/ ENT |
4-383 | Complete | ISO | 13078-3 First edition 2023-05 | Dentistry - Dental furnace - Part 3: Test method for the evaluation of high temperature sintering furnace measurement with a separate thermocouple |
| ANSI ADA | Standard No. 209-2024 | Dentistry - Test Method for the Evaluation of High Temperature Sintering Furnace Measurement with a Separate Thermocouple | ||||
| 05/25/2026 | Dental/ ENT |
4-384 | Complete | ISO | 13397-1 First edition 1995-12 | Periodontal curettes, dental scalers and excavators - Part 1: General requirements |
| 05/25/2026 | Dental/ ENT |
4-385 | Complete | ISO | 13397-2 Second edition 2005-06 [Including AMD1:2012] | Dentistry - Periodontal curettes, dental scalers and excavators - Part 2: Periodontal curettes of Gr-type [Including AMENDMENT 1 (2012)] |
| 05/25/2026 | Dental/ ENT |
4-386 | Complete | ISO | 13397-3 First edition 1996-09 | Periodontal curettes, dental scalers and excavators - Part 3: Dental scalers - H-type |
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