FDA applicant

Zhermack S.P.A.

Bend, OR19 decisions1996–20095 recalls

FDA records 19 decisions for Zhermack S.P.A. (Bend, OR) from 1996 to 2009: 19 510(k) clearances. All are in product code ELW (Material, Impression). 5 recalls are 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 S.P.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 3 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

3in 2016

2007high 3 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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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 Dental Production 11

Zhermack S.P.A.

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?

What has been recalled?

Other applicant names beginning “Zhermack”