Recognized standard
Standard No. 39-2006 (R2011)
FDA recognition 4-149 · ANSI · Dental/ENT
Key facts
| Recognition number | 4-149 |
|---|---|
| Designation | Standard No. 39-2006 (R2011) |
| Title | Pit and Fissure Sealants |
| Standards developer | American National Standards Institute |
| Specialty area | Dental/ENT |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard specifies requirements and test methods for resin-based materials suitable for sealing pits and fissures in teeth. This standard covers both chemically cured and external-energy-activated materials. |
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: