Precision® SPD1511
Precision® SPD1511 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 D813SPD15110), 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 | NumberD813SPD15110 | 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 D813SPD15110 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K040053
- Listed FDA GUDID D813SPD15110
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- Withdrawn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
- SPD1511
- Primary DI / UDI-DI
- D813SPD15110
- 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.
- DuoSil NONE by Bukwang Inc.
- trayloc A Spray 15 ml 03392 by DETAX GmbH & Co. KG
- IMPRESSION TRAY S 1027-7 by Dental Expert
- Freealgin by Zhermack S.P.A.
- Caulk® Tray Adhesive 626155 by Dentsply International
- Model Resin YH-M-H60-001 by Sichuan Yonghe Medical Technology Co., Ltd.
- tgputty PT 9717 by Technical and General Limited