| ISO 24234 Second edition 2015-05-01 Dentistry - Dental Amalgam |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 4-224 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
| FDA Tech | Michael Adjodha FDA/OMPT/CDRH/ODE/DAGID/DEDB 301-796-6276 michael.adjodha@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3070 | Alloy, Amalgam | Class 2 | EJJ |
| §872.3070 | Mercury | Class 2 | ELY |
| Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073311.htm |