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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 041 Date of Entry 04/04/2016 
FR Recognition Number 4-224
Standard
ISO  24234 Second edition 2015-05-01
Dentistry - Dental Amalgam
Scope/Abstract
This International Standard specifies the requirements and test methods for dental amalgam alloys 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 (including those for dental mercury).

It is applicable to dental amalgam alloys supplied in the form of a free-flowing powder in bulk, or a powder compressed to form a tablet, or a powder in a capsule (i.e. pre-capsulated).

With respect to dental mercury, the scope is limited solely to dental mercury which is supplied pre-capsulated or in pre-dosed sachets. Both are limited to a mass sufficient for one mix. The mass of dental mercury in one capsule or sachet shall be sufficient to produce a homogeneous plastic mix, appropriate for a small or medium d restoration in a single tooth. This International Standard is not applicable to mercury supplied in masses greater than this in a single primary container (i.e. dental mercury in bulk). Dental mercury supplied in bulk volumes will not conform to this International Standard.

This International Standard does not exclude the supply of dental amalgam alloy or dental mercury separately.

This International Standard is not applicable to 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.

NOTE Dental mercury is at least 99,99 % pure, and as such, it is a metallic element of high commercial purity, and not an alloy
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FDA recognition of ISO 24234 Second edition 2015-05 [Rec# 4-224] will be superseded by recognition of ISO 24234 Third edition 2021-08 [Rec# 4-315].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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