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S & C Polymer GmbH

GermanyFDA 510(k) applicant, unverified FDA FEI 3003667632

Devices
19
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

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.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue19

Newest first, rows 1-19 of 19

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  • S & C -Bracket Adhesives Ref K031420

    Class II
    Active 510(k) 510(k) II
  • Root Canal Xr Ref K083062

    Class II
    Active 510(k) 510(k) II
  • Resin Cem Ref K011431

    Class II
    Active 510(k) 510(k) II
  • Lc Flowfill Ref K990108

    Class II
    Active 510(k) 510(k) II
  • Classic Cem Ref K011064

    Class II
    Active 510(k) 510(k) II
  • Phoglass Fill, Core, Cem, Seal, Prime And Phoglass Protect Ref K082115

    Class II
    Active 510(k) 510(k) II
  • Lc Provifill Ref K010012

    Class II
    Active 510(k) 510(k) II
  • Dc Provi Cem Esthetic, Esthetic Multi F, Implant Ref K091735

    Class II
    Active 510(k) 510(k) II
  • S&C-Self Etch Pr-Bond Ref K042614

    Class II
    Active 510(k) 510(k) II
  • Carboxylate Cem, Phosphate Cem Ref K081702

    Class II
    Active 510(k) 510(k) II
  • A-Soft Reliner Ref K984483

    Class II
    Active 510(k) 510(k) II
  • Provi Cement Ref K973201

    Class II
    Active 510(k) 510(k) II
  • S & C Hydro Vinyl Polysiloxane Impression Material Ref K012767

    Class II
    Active 510(k) 510(k) II
  • Lc Microfill Ref K991442

    Class II
    Active 510(k) 510(k) II
  • Ceram-Prime Ref K002502

    Class II
    Active 510(k) 510(k) II
  • Hard Reliner Ref K011277

    Class II
    Active 510(k) 510(k) II
  • Phoglass Cem Ref K083766

    Class II
    Active 510(k) 510(k) II
  • Dc-Core Ref K984097

    Class II
    Active 510(k) 510(k) II
  • S & C Vinyl Polysiloxane Impression Material Ref K951075

    Class II
    Active 510(k) 510(k) II

Rows 1-19 of 19

Company 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.

Generated automatically from registry data and not verified by a human reviewer.