Recognized Consensus Standards: Medical Devices
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Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 12/22/2025 | Dental/ ENT |
4-361 | Complete | ISO | 3630-2 Fourth edition 2023-02 | Dentistry - Endodontic instruments - Part 2: Enlargers |
| ANSI ADA | Standard No. 101-2-2025 | 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. 101-3-2025 | Dentistry - Endodontic Instruments - Part 3: Compactors | ||||
| 12/23/2024 | Dental/ ENT |
4-333 | Complete | ISO | 3630-4 Second edition 2023-08 | Dentistry - Endodontic instruments - Part 4: Auxiliary instruments |
| ANSI ADA | Standard No. 101-4-2025 | Dentistry - Endodontic Instruments - Part 4: Auxiliary Instruments | ||||
| 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 | ||||
| 12/18/2023 | 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 | ||||
| 12/22/2025 | Dental/ ENT |
4-351 | Complete | ISO | 6877 Fourth edition 2025-08 | Dentistry - Endodontic obturating materials |
| 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 |
| 12/23/2019 | 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 |
| 05/25/2026 | Dental/ ENT |
4-398 | Complete | ISO | 23940 First edition 2021-04 | Dentistry - Excavators |
| 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 | ||||
| 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 |
| 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 | ||||
| 12/18/2023 | Dental/ ENT |
4-319 | Partial | ISO | 17730 Second edition 2020-09 | Dentistry - Fluoride varnishes |
| ANSI ADA | Standard No. 117-2022 | Dentistry - Fluoride Varnishes | ||||
| 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 |
| 05/29/2024 | 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 |
| 12/22/2025 | Dental/ ENT |
4-365 | Complete | ISO | 6873 Third edition 2013-04 | Dentistry - Gypsum products |
| ANSI ADA | Standards No. 25-2015 (R2021) | Dental Gypsum Products | ||||
| 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 | ||||
| 01/30/2014 | Dental/ ENT |
4-180 | Complete | ISO | 9168 Third edition 2009-07-15 | Dentistry - Hose connectors for air driven dental handpieces |
| 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 | ||||
| 07/15/2019 | Dental/ ENT |
4-259 | Partial | ISO | 14801 Third edition 2016-11-01 | Dentistry - Implants - Dynamic loading test for endosseous dental implants |
| ANSI ADA | Standard No. 127-2018 | Dynamic Loading Test for Endosseous Dental Implants | ||||
| 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 | ||||
| 12/19/2022 | Dental/ ENT |
4-296 | Complete | ISO | 9873 Fourth edition 2019-03 | Dentistry - Intra-oral mirrors |
| ANSI ADA | Standard No. 191-2020 | Intra-Oral Mirrors | ||||
| 12/18/2023 | Dental/ ENT |
4-321 | Complete | ISO | 23450 First edition 2021-03 | Dentistry - Intraoral camera |
| ANSI ADA | Standard No. 213-2024 | Dentistry - Intra Oral Camera | ||||
| 12/20/2021 | Dental/ ENT |
4-289 | Complete | ISO | 18556 Frist edition 2016-04 | Dentistry - Intraoral spatulas |
| 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 | ||||
| 12/18/2023 | Dental/ ENT |
4-322 | Complete | ISO | 18675 First edition 2022-05 | Dentistry - Machinable ceramic blanks |
| 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 | ||||
| 12/19/2022 | Dental/ ENT |
4-297 | Complete | ISO | 20126 Third edition 2022-03 | Dentistry - Manual toothbrushes - General requirements and test methods |
| 05/26/2025 | Dental/ ENT |
4-347 | Complete | ISO | 22254 First edition 2005-08 | Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection |
| 05/25/2026 | Dental/ ENT |
4-395 | Complete | ISO | 21850-1 First edition 2020-04 | Dentistry - Materials for dental instruments - Part 1: Stainless steel |
| ANSI ADA | Standard No. 196-2021 | Materials for Dental Instruments - Part 1: Stainless Steel | ||||
| 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 |
| 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 | ||||
| 05/25/2026 | Dental/ ENT |
4-391 | Complete | ISO | 16498 First edition 2013-07 | Dentistry - Minimal dental implant data set for clinical use |
| ANSI ADA | Standard No. 172-2019 | Minimal Dental Implant Data Set for Clinical Use | ||||
| 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 | ||||
| 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 | ||||
| 06/07/2021 | Dental/ ENT |
4-283 | Complete | ISO | 16409 Second edition 2016-10 | Dentistry - Oral care products - Manual interdental brushes |
| ANSI ADA | Standard No. 125-2018 | Manual Interdental Brushes | ||||
| 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 | ||||
| 12/22/2025 | Dental/ ENT |
4-356 | Complete | ANSI ADA | Standard No. 32-2024 | Dentistry - Orthodontic Wires |
| 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 |
4-387 | Complete | ISO | 13397-5 First edition 2015-09 | Dentistry - Periodontal curettes, dental scalers and excavators - Part 5: Jacquette scalers |
| 05/25/2026 | Dental/ ENT |
4-394 | Complete | ISO | 21672-1 First edition 2012-04 | Dentistry - Periodontal probes - Part 1: General requirements |
| ANSI ADA | Standard No. 169-2019 | Periodontal Probes: General Requirements | ||||
| 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 | ||||
| 12/22/2025 | Dental/ ENT |
4-353 | Complete | ISO | 20127 Third edition 2025-05 | Dentistry - Physical properties of powered toothbrushes |
| 12/18/2023 | Dental/ ENT |
4-323 | Complete | ISO | 5139 First edition 2023-05 | Dentistry - Polymer-based composite machinable blanks |
| 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 | ||||
| 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 |
| 05/26/2025 | Dental/ ENT |
4-344 | Complete | ANSI ADA | Standard No. 186-2024 | Dentistry - Polymer-based Machinable Blanks |
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