FDA applicant

S&C Polymer Silicon- Und Composite Spezialitaten GmbH

Elmshorn, DE3 decisions2020–20230 recalls

FDA records 3 decisions for S&C Polymer Silicon- Und Composite Spezialitaten GmbH (Elmshorn, DE) from 2020 to 2023: 3 510(k) clearances. Most are in product codes KLE (Agent, Tooth Bonding, Resin) and EJK (Liner, Cavity, Calcium Hydroxide). Its devices cite 4 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 Spezialitäten 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 Spezialitaten GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — S&C Polymer Silicon- Und Composite Spezialitaten GmbH by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like S&C Polymer Silicon- Und Composite…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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S&C Polymer Silicon- Und Composite Spezialitaten GmbH

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?