Astra Tech AB: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Astra Tech AB” (first 2007, latest 2013), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 160 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 160 |
| 2013 | 1 | 217 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 6 | 6 |
| NHA | Abutment, Implant, Dental, Endosseous | 3 | 3 |
| EZD | Catheter, Straight | 1 | 1 |
Review panels
Most recent Astra Tech AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K121810 | OSSEOSPEED ANGLED ABUTMENT EV | NHA | 2013-01-23 | 217 |
| K120414 | OSSEOSPEED PLUS | DZE | 2012-07-31 | 172 |
| K113424 | LOFRIC SINGLE USE URINARY CATHETER | EZD | 2012-04-17 | 148 |
| K111287 | ASTRA TECH IMPLANT SYSTEM | DZE | 2011-09-26 | 143 |
| K101005 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | NHA | 2011-06-21 | 435 |
| K101732 | ASTRA TECH IMPLANT SYSTEM | DZE | 2011-02-23 | 247 |
| K091239 | ASTRA TECH IMPLANT SYSTEM | DZE | 2009-09-22 | 148 |
| K080156 | OSSEOSPEED TM PROFILE SYSTEM | DZE | 2008-09-17 | 238 |
| K080396 | OSSEOSPEED NARROW | DZE | 2008-04-30 | 77 |
| K072624 | ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT | NHA | 2007-10-01 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Astra Tech AB.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Astra Tech, Inc. (28 510(k)s)
- Astra Meditec AB (3 510(k)s)
- Astra Pharmaceutical Products, Inc. (2 510(k)s)
- Astra Orthomed, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Astra Tech AB?
FDA lists 10 510(k) clearances under the applicant name “Astra Tech AB” (first 2007, latest 2013), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Astra Tech AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Astra Tech AB is 160 days.
Which FDA product codes appear under Astra Tech AB?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 6); NHA (Abutment, Implant, Dental, Endosseous, 3); EZD (Catheter, Straight, 1).
Next steps
- See all 10 Astra Tech AB clearances with predicates and recalls
- Run predicate analysis for product code DZE, Astra Tech AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.