Precision® SPD1509
Precision® SPD1509 is a Class II device made by Den-Mat Holdings, LLC, cleared under FDA 510(k) K040053 on 25 Mar 2004 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI D813SPD15090), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD813SPD15090 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040053 | Date25 Mar 2004 | StatusActive |
Official records
- FDA 510(k) database K040053
Across registries
- FDA 510(k) K040053 decided 25 Mar 2004 Active
- FDA GUDID UDI-DI D813SPD15090 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K040053
- Listed FDA GUDID D813SPD15090
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Precision®
- Generic name
- Silicone dental impression material
- Model / Ref / Catalog
- SPD1509
- Primary DI / UDI-DI
- D813SPD15090
- 510(k) Number
- FDA product code
- ELW
- GMDN term
- Silicone dental impression material
- Device class
- Class II
- Regulation number
- 872.3660
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Silicone dental impression material.