Recognized Consensus Standards: Medical Devices
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Standards
Developing Organization |
Standard Designation Number and Date |
Standard Title (click for recognition information) |
| 07/06/2020 | Dental/ ENT |
4-263 | Complete | ISO | 9693 Third edition 2019-10 | Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems |
| ANSI ADA | Standard No. 38-2020 | Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems | ||||
| 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 | ||||
| 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 | ||||
| 12/21/2020 | Dental/ ENT |
4-269 | Complete | ISO | 3964 Third edition 11-2016 | Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)] |
| ANSI ADA | Standard No. 158-2020 | Coupling Dimensions for Dental Handpiece Connectors | ||||
| 12/18/2023 | Dental/ ENT |
4-315 | Complete | ISO | 24234 Third edition 2021-08 | Dentistry - Dental Amalgam |
| 04/04/2016 | Dental/ ENT |
4-224 | Complete | ISO | 24234 Second edition 2015-05-01 | Dentistry - Dental Amalgam |
| 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 |
| 12/20/2021 | Dental/ ENT |
4-284 | Complete | ISO | 10873 Second edition 2021-07 | Dentistry - Denture adhesives |
| 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 | ||||
| 06/07/2021 | Dental/ ENT |
4-278 | Complete | ISO | 4823 Fifth edition 2021-02 | Dentistry - Elastomeric impression and bite registration materials |
| ANSI ADA | Standard No. 19-2022 | Elastomeric Impression and Bite Registration | ||||
| 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 | ||||
| 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 |
| 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 | ||||
| 01/14/2019 | Dental/ ENT |
4-257 | Partial | ISO | 17730 First edition 2014-11-01 | 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 |
| 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 |
| 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 |
4-301 | 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 |
| 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 |
| 12/19/2022 | Dental/ ENT |
4-297 | Complete | ISO | 20126 Third edition 2022-03 | Dentistry - Manual toothbrushes - General requirements and test methods |
| 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 | ||||
| 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 | ||||
| 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 | ||||
| 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 | ||||
| 12/18/2023 | 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 |
4-323 | 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 | ||||
| 01/14/2019 | Dental/ ENT |
4-248 | Complete | ISO | 10477 Third edition 2018-06 | Dentistry - 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 |
| 04/04/2016 | Dental/ ENT |
4-222 | Complete | ISO | 6874 Third edition 2015-09-01 | Dentistry - Polymer-based pit and fissure sealants |
| 01/30/2014 | Dental/ ENT |
4-181 | Complete | ISO | 4049 Fourth edition 2009-10-01 | Dentistry - Polymer-based restorative materials |
| 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 | ||||
| 01/14/2019 | Dental/ ENT |
4-252 | Complete | ISO | 10650 Second edition 2018-08 | Dentistry - Powered polymerization activators |
| ANSI ADA | Standard No. 48-2020 | Curing Lights (Powered Polymerization Activators) | ||||
| 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 |
4-246 | 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 |
4-318 | Complete | ISO | 20749 Second edition 2023-06 | Dentistry - Pre-capsulated dental amalgam |
| 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 | ||||
| 01/30/2014 | 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 | ||||
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