510(k) Report

FDA applicant

S&C Polymer Silicon- Und Composite Spezialitaeten

Elmshorn, Schleswig-Holstein, DE4 decisions2013–20190 recalls

FDA records 4 decisions for S&C Polymer Silicon- Und Composite Spezialitaeten (Elmshorn, Schleswig-Holstein, DE) from 2013 to 2019: 4 510(k) clearances. Most are in product codes EBF (Material, Tooth Shade, Resin) and EJK (Liner, Cavity, Calcium Hydroxide). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “S&C Polymer Silicon- Und Composite Spezialitaeten GmbH”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided S&C Polymer Silicon- Und Composite Spezialitaeten’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2013: 12015: 12019: 2
2013high 2 (2019) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — S&C Polymer Silicon- Und Composite Spezialitaeten by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBFMaterial, Tooth Shade, Resin2decisions
  • EJKLiner, Cavity, Calcium Hydroxide1decision
  • KIFResin, Root Canal Filling1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K182778LC Glossfill XRS&C Polymer Silicon- Und Composite Spezialitaeten GmbH · 20191cites it

What has FDA decided for it lately?

  • K182780XP CompositeS&C Polymer Silicon- Und Composite Spezialitaeten GmbH · 2019
  • K182778LC Glossfill XRS&C Polymer Silicon- Und Composite Spezialitaeten GmbH · 2019
  • K141047LC Calciumhydroxide LinerS&C Polymer Silicon- Und Composite Spezialitaeten · 2015
  • K130125Mta CementsS&C Polymer Silicon- Und Composite Spezialitaeten · 2013

All 2 as S&C Polymer Silicon- Und Composite Spezialitaeten →All 2 as S&C Polymer Silicon- Und Composite Spezialitaeten GmbH →