Recognized standard
21563 First edition 2013-08-15 Standard No. 128-2015
FDA recognition 4-240 · ISO · Dental/ENT
Key facts
| Recognition number | 4-240 |
|---|---|
| Designation | 21563 First edition 2013-08-15 Standard No. 128-2015 |
| Title | Dentistry - Hydrocolloid impression materials Hydrocolloid Impression Materials |
| Standards developer | International Organization for Standardization |
| Specialty area | Dental/ENT |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This International Standard specifies the requirements and tests for helping determine whether the elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for… |
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: