S & C Polymer GmbH
GermanyFDA 510(k) applicant, unverified FDA FEI 3003667632
- Devices
- 19
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What S & C Polymer GmbH makes
S & C Polymer GmbH manufactures dental materials for endodontic and restorative procedures, including resin-based root canal sealants (ROOT CANAL XR, LC FLOWFILL, LC PROVIFILL), dental cements (CLASSIC CEM, PHOGLASS FILL/CEM/SEAL/PRIME/PROTECT, PROVI CEMENT, DC PROVI CEM ESTHETIC), and impression materials (S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL). Their portfolio also includes bonding agents (S&C-SELF ETCH PR-BOND), relining materials (A-SOFT RELINER), and various composite cements (RESIN CEM, CARBOXYLATE CEM, PHOSPHATE CEM).
The company’s dental products are classified as Class II devices under FDA regulations and are supported by 510(k) clearances. Their portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. medical device authorization requirements. The manufacturer is based in the United States.
Catalogue
Search and filter all 19 devicesCompany details
- FDA FEI number
- 3003667632
- Address
- ROBERT-BOSCH-STRASSE 2, ELMSHORN Schleswig-Holstein
Frequently asked questions
How many devices does S & C Polymer GmbH have in the registry?
The registry currently lists 19 devices for S & C Polymer GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list S & C Polymer GmbH's devices?
Among its 19 most recently registered devices, S & C Polymer GmbH has devices listed in FDA 510(k) (19 devices).
What risk classes do S & C Polymer GmbH's devices fall under?
Among its 19 most recently registered devices, the classes recorded for S & C Polymer GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from S & C Polymer GmbH in the registry?
The most recently registered devices listed for S & C Polymer GmbH include S & C -BRACKET ADHESIVES, ROOT CANAL XR, RESIN CEM and LC FLOWFILL.