Not currently registered with FDA under this name
S&C Polymer Silicon- Und Composite Spezialitaten GmbH
Elmshorn, Germany. Named as applicant on 3 dental 510(k) clearances between 2020 and 2023. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32020–2023
- Markets registered in
- 428 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name S&C Polymer Silicon- Und Composite Spezialitaten 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 | Applicant | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | 3 clearances | 2020–2023 | Below |
| European Union | EUDAMED | Manufacturer | S & C Polymer, Silicon- und Composite Spezialitäten GmbH | 18 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | S&C Polymer Silicon-und Composite Spezialitaten GmbhS&C Polymer Silicon-und Composite Spezialitaten GmbH | 9 | 2015–2017 | Pure Global AI |
| China | NMPA | Registration holder | 聚合硅复材料有限公司S&C PolymerSilicon- und Composite-Spezialitäten GmbH | 1 | — | 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
510(k) clearances
Clearances on which FDA names S&C Polymer Silicon- Und Composite Spezialitaten GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 6 Mar 2023 | K222445 | LC ChromeFlow | EBF Resin Tooth Shade Material |
| 6 Jul 2022 | K221033 | UniPrime A, UniPrime E, UniPrime E/C | KLE Resin Tooth Bonding Agent |
| 20 Nov 2020 | K202413 | LC ResinCal PC | EJK Calcium Hydroxide Cavity Liner |
Some of these clearances are listed with FDA today by another company: S & C Polymer GmbH (2), Prismatik Dentalcraft, Inc. (1), Kulzer, LLC (1), Directa AB (1), NuSmile, Ltd. (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.