FDA applicant

Straumann Institute, Ltd.

Brookline, MA1 decision1990–19900 recalls

FDA records 1 decision for Straumann Institute, Ltd. (Brookline, MA) in 1990: 1 510(k) clearance. All are in product code DZE (Implant, Endosseous, Root-Form). 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 Straumann Institute, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Straumann Institute, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Straumann”

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

Straumann USA 66 The Straumann Co. 15 Straumann USA, LLC (On Behalf of Institut Straumann Ag) 5 Straumann Manufacturing, Inc. 4

Straumann Institute, Ltd.

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 “Straumann”