FDA applicant

Zhermack Dental Production

(Rovigo) Italy, IT11 decisions1994–19950 recalls

FDA records 11 decisions for Zhermack Dental Production ((Rovigo) Italy, IT) from 1994 to 1995: 11 510(k) clearances. All are in product code ELW (Material, Impression). No recall is linked to its devices.

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 Zhermack Dental Production’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zhermack Dental Production since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zhermack Dental Production by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zhermack Dental Production’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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Other applicant names beginning “Zhermack”

FDA records each applicant name separately; these may or may not be the same firm.

Zhermack S.P.A. 19

Zhermack Dental Production

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Zhermack”