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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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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
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		 4-305 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
05/29/2023 General Plastic Surgery/
General Hospital		 6-486 Complete ISO 10535 Third edition 2021-10 Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
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