510(k) Report

FDA applicant

H.C. Starck Ceramics GmbH

North Reading, MA4 decisions2008–20150 recalls

FDA records 4 decisions for H.C. Starck Ceramics GmbH (North Reading, MA) from 2008 to 2015: 4 510(k) clearances. All are in product code EIH (Powder, Porcelain). Its devices cite 9 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “H.C. Starck Ceramics GmbH & Co.Kg”.

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 H.C. Starck Ceramics GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008: 12013: 12014: 12015: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — H.C. Starck Ceramics GmbH by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like H.C. Starck Ceramics GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report