FDA applicant

Altatec GmbH

San Diego, CA14 decisions2006–20200 recalls

FDA records 14 decisions for Altatec GmbH (San Diego, CA) from 2006 to 2020: 14 510(k) clearances. Most are in product codes NHA (Abutment, Implant, Dental, Endosseous) and DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 154 days from receipt to decision, against 202 for FDA’s reviews in the same codes and years. Its devices cite 29 predicates, 12 of them its own earlier devices. 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 Altatec GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007high 3 (2016) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Altatec GmbH’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 “Altatec”

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

Altatec Biotechnologies 4 Altatec Biotechnologies N.A., Inc. 1

Altatec GmbH

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Altatec”