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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 4-315
Standard
ISO  24234 Third edition 2021-08
Dentistry - Dental Amalgam
Scope/Abstract
This document specifies the requirements and test methods for dental amalgam alloy powder and dental mercury that are suitable for the preparation of dental amalgam together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking.

NOTE Two of the requirements apply only to dental mercury (as supplied). All of the other requirements apply to the dental amalgam alloy (as supplied) and dental amalgam.

This document is not applicable to dental amalgam alloy powder and dental mercury supplied in a pre-capsulated form.

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.
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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FDA recognition of ISO 24234 Second edition 2015-05 [Rec# 4-224] will be superseded by recognition of ISO 24234 Third edition 2021-08 [Rec# 4-315]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-224] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-224] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3070 Alloy, Amalgam Class 2 EJJ
§872.3070 Mercury Class 2 ELY
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy, 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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