Recognized standard
6874 Third edition 2015-09-01
FDA recognition 4-222 · ISO · Dental/ENT
Key facts
| Recognition number | 4-222 |
|---|---|
| Designation | 6874 Third edition 2015-09-01 |
| Title | Dentistry - Polymer-based pit and fissure sealants |
| 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 requirements and test methods for polymer-based materials intended for sealing pits and fissures in teeth. This International Standard covers both self-curing and external-energy-activated materials. |
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: