Manufacturer registered with FDA
S & C Polymer GmbH
ELMSHORN, Germany. Lists 14 dental device types with FDA across 1 registered establishment, and holds 20 510(k) clearances as applicant.
- Device types listed
- 14
- Brands and models
- 0
- 510(k) clearances
- 201995–2009
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name S & C Polymer GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | S & C Polymer GmbH | 20 clearances | 1995–2009 | Below |
| Taiwan | TFDA | Manufacturer | S&C POLYMER GMBH | 1 | 2010–2010 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What S & C Polymer GmbH currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names S & C Polymer GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 25 Sep 2009 | K091735 | DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT | EMA Dental Cement |
| 12 Mar 2009 | K083062 | ROOT CANAL XR | KIF Root Canal Filling Resin |
| 2 Mar 2009 | K083766 | PHOGLASS CEM | EMA Dental Cement |
| 15 Jan 2009 | K082115 | PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT | EMA Dental Cement |
| 5 Sep 2008 | K081702 | CARBOXYLATE CEM, PHOSPHATE CEM | EMA Dental Cement |
| 22 Nov 2004 | K042614 | S&C-SELF ETCH PR-BOND | KLE Resin Tooth Bonding Agent |
| 20 Aug 2003 | K031420 | S & C -BRACKET ADHESIVES | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 1 Nov 2001 | K012767 | S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW Impression Material |
| 26 Jun 2001 | K011277 | HARD RELINER | EBI Rebasing Repairing Relining Denture Resin |
| 11 Jun 2001 | K011431 | RESIN CEM | EMA Dental Cement |
| 17 May 2001 | K011064 | CLASSIC CEM | EMA Dental Cement |
| 14 Feb 2001 | K010012 | LC PROVIFILL | EBG Resin Temporary Crown and Bridge |
| 8 Nov 2000 | K002502 | CERAM-PRIME | KLE Resin Tooth Bonding Agent |
| 3 Jun 1999 | K991442 | LC MICROFILL | EBF Resin Tooth Shade Material |
| 9 Mar 1999 | K990108 | LC FLOWFILL | EBF Resin Tooth Shade Material |
| 18 Feb 1999 | K984483 | A-SOFT RELINER | EBI Rebasing Repairing Relining Denture Resin |
| 9 Feb 1999 | K984097 | DC-CORE | EBF Resin Tooth Shade Material |
| 20 Jan 1999 | K984484 | LC MICROHYBRID | EBF Resin Tooth Shade Material |
| 5 Jun 1998 | K973201 | PROVI CEMENT | EMA Dental Cement |
| 31 Mar 1995 | K951075 | S & C VINYL POLYSILOXANE IMPRESSION MATERIAL | ELW Impression Material |
Some of these clearances are listed with FDA today by another company: Den-Mat Holdings, LLC (8), Zest Anchors, LLC (4), Prismatik Dentalcraft, Inc. (3), Inter-Med, Inc. (2), Peter Brasseler Holdings, LLC (1), Sherpa (1).
Also lists devices cleared under other names
S & C Polymer GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: S&C Polymer Silicon- Und Composite Spezialitaeten GmbH (4), Silicon-Und Composite Spezialitaten GmbH (3), S&C Polymer Silicon- Und Composite Spezialitaten GmbH (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| S & C POLYMER GMBHFDA reg. 9681210 | ELMSHORN Schleswig-Holstein, Germany | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9019395). 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.