Altatec GmbH: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Altatec GmbH” (first 2006, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 120 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 | 1 | 358 |
| 2013 | 0 | — |
| 2014 | 1 | 223 |
| 2015 | 2 | 100 |
| 2016 | 3 | 132 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 298 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Altatec GmbH took a median 298 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 9 | 9 |
| DZE | Implant, Endosseous, Root-Form | 5 | 5 |
Review panels
- Dental (14)
Most recent Altatec GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | DZE | 2020-09-29 | 298 |
| K160784 | CAM Titanium Blanks | NHA | 2016-09-14 | 176 |
| K153779 | Abutment for Bridges | NHA | 2016-03-31 | 91 |
| K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) | NHA | 2016-01-12 | 132 |
| K151599 | iSy Implant System | DZE | 2015-10-02 | 112 |
| K143337 | CONELOG Titanium base CAD/CAM | NHA | 2015-02-17 | 89 |
| K133991 | ISY | DZE | 2014-08-06 | 223 |
| K113779 | CONELOG IMPLANT SYSTEM | DZE | 2012-12-14 | 358 |
| K103252 | CAMLOG VARIO SR ABUTMENTS | NHA | 2011-01-10 | 68 |
| K090347 | CAMLOG ABUTMENTS PS | NHA | 2009-06-18 | 127 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Altatec GmbH.
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.
- Altatec Biotechnologies (4 510(k)s)
- Altatec Biotechnologies N.A., Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Altatec GmbH?
FDA lists 14 510(k) clearances under the applicant name “Altatec GmbH” (first 2006, latest 2020), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Altatec GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Altatec GmbH is 120 days.
Which FDA product codes appear under Altatec GmbH?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 9); DZE (Implant, Endosseous, Root-Form, 5).
Next steps
- See all 14 Altatec GmbH clearances with predicates and recalls
- Run predicate analysis for product code NHA, Altatec GmbH'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.