FDA applicant

Astra Tech, Inc.

San Diego, CA38 decisions1994–20133 recalls

FDA records 38 decisions for Astra Tech, Inc. (San Diego, CA) from 1994 to 2013: 38 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Its devices cite 81 predicates, 45 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Astra Tech AB”.

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 Astra Tech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 7 (2011) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

3in 2020

2007high 3 (2020) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Astra Tech, Inc.’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

Other applicant names beginning “Astra”

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

Astra Meditec AB 3 Astra Pharmaceutical Products, Inc. 2 Astra Orthomed, Inc. 1

Astra Tech, Inc.

Which product codes does it file in?

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?

What has been recalled?

Other applicant names beginning “Astra”