Astra Tech, Inc.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Astra Tech, Inc.” (first 1994, latest 2012), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 108 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 | 3 | 146 |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 13 | 13 |
| DZE | Implant, Endosseous, Root-Form | 11 | 11 |
| GBM | Catheter, Urethral | 3 | 3 |
| EZD | Catheter, Straight | 1 | 1 |
Review panels
- Dental (24)
- Gastroenterology and Urology (4)
Most recent Astra Tech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122078 | LOFRIC PRIMO, LOFRIC HYDRO-KIT | EZD | 2012-10-31 | 107 |
| K120338 | ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA | NHA | 2012-07-05 | 153 |
| K113003 | ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... | NHA | 2012-03-01 | 146 |
| K112138 | ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT | NHA | 2011-12-01 | 128 |
| K110640 | ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT | NHA | 2011-06-10 | 98 |
| K110356 | ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT | NHA | 2011-06-10 | 123 |
| K103759 | ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT | NHA | 2011-04-08 | 106 |
| K101004 | ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT | NHA | 2010-08-16 | 126 |
| K093780 | ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT | NHA | 2010-04-16 | 128 |
| K093483 | ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT | NHA | 2009-12-22 | 43 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Astra Tech, Inc..
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 AB (10 510(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, Inc.?
FDA lists 28 510(k) clearances under the applicant name “Astra Tech, Inc.” (first 1994, latest 2012), across 4 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Astra Tech, Inc. is 108 days.
Which FDA product codes appear under Astra Tech, Inc.?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 13); DZE (Implant, Endosseous, Root-Form, 11); GBM (Catheter, Urethral, 3).
Next steps
- See all 28 Astra Tech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NHA, Astra Tech, Inc.'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.