Recognized standard

24234 Second edition 2015-05-01

FDA recognition 4-224 · ISO · Dental/ENT

Key facts

Recognition number 4-224
Designation 24234 Second edition 2015-05-01
Title Dentistry - Dental Amalgam
Standards developer International Organization for Standardization
Specialty area Dental/ENT
Date of entry Apr 4, 2016
Device classes Class 2
Scope (excerpt) 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…

At a glance

  • 1–9 Product codes
  • 1–9 FDA guidance documents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA-recognized consensus standards

The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.

Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date:

Browse all FDA-recognized consensus standards