Not currently registered with FDA under this name
Silicon-Und Composite Spezialitaten GmbH
Elmshorn, Germany. Named as applicant on 4 dental 510(k) clearances between 1995 and 1999. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 41995–1999
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Silicon-Und Composite Spezialitaten GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Nov 1999 | K992001 | TRAY-LINK | ELW Impression Material |
| 9 Jul 1999 | K991450 | ETCHING GEL | EBF Resin Tooth Shade Material |
| 18 Apr 1996 | K960938 | PROV-KB | EBG Resin Temporary Crown and Bridge |
| 22 Sep 1995 | K953476 | MULTI-PRIME AKA/MONO-PRIME | KLE Resin Tooth Bonding Agent |
Some of these clearances are listed with FDA today by another company: S & C Polymer GmbH (3), Den-Mat Holdings, LLC (1), Crown Delta Corp. (1), Zest Anchors, LLC (1), Lang Dental Mfg. Co., Inc. (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.