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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 061 Date of Entry 12/18/2023 
FR Recognition Number 4-318
Standard
ISO  20749 Second edition 2023-06
Dentistry - Pre-capsulated dental amalgam
Scope/Abstract
This document specifies the requirements and test methods for dental amalgam products supplied to the user in capsules, pre-dosed with dental amalgam alloy powder and dental mercury in quantities suitable for the creation of a single dental restoration.

This document specifies the requirements and test methods for the capsule and the requirements for packaging and marking.

This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration.

This document is restricted to dental amalgam products marketed in pre-capsulated form, alone. Other products intended for use in the production of dental amalgam restorations (dental amalgam alloy as a free-flowing powder supplied in bulk masses, dental amalgam alloy powder supplied as compressed tablets and dental mercury sachets) are described in ISO 24234.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO 20749 First edition 2017-03 [Rec# 4-246] will be superseded by recognition of ISO 20749 Second edition 2023-06 [Rec# 4-318]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-246] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-246] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3070 Dental Amalgam Class 2 OIV
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff, issued July 2009.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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