Recognized standard
21563 Second edition 2021-08 Standard No. 128-2022
FDA recognition 4-301 · ISO · Dental/ENT
Key facts
| Recognition number | 4-301 |
|---|---|
| Designation | 21563 Second edition 2021-08 Standard No. 128-2022 |
| Title | Dentistry - Hydrocolloid impression materials Hydrocolloid Impression Materials |
| 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 the requirements and test methods for hydrocolloid impression materials. This document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended… |
At a glance
- None 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: