Recognized standard

22674 Third edition 2022-08

FDA recognition 4-300 · ISO · Dental/ENT

Key facts

Recognition number 4-300
Designation 22674 Third edition 2022-08
Title Dentistry - Metallic materials for fixed and removable restorations and appliances
Standards developer International Organization for Standardization
Specialty area Dental/ENT
Date of entry May 29, 2023
Device classes Class 2
Scope (excerpt) This document specifies requirements and test methods for metallic materials that are suitable for the fabrication of dental restorations and appliances. Included are metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses. Furthermore, this…

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