Altatec GmbH
WIMSHEIM Baden-Wurttemberg, DE
ALTATEC GMBH appears in FDA device records in WIMSHEIM Baden-Wurttemberg, DE. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Altatec GmbH between 2006 and 2020. The busiest year on record is 2016, with 3. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 3 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | DZE | Substantially Equivalent | |
| K160784 | CAM Titanium Blanks | NHA | Substantially Equivalent | |
| K153779 | Abutment for Bridges | NHA | Substantially Equivalent | |
| K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) | NHA | Substantially Equivalent | |
| K151599 | iSy Implant System | DZE | Substantially Equivalent | |
| K143337 | CONELOG Titanium base CAD/CAM | NHA | Substantially Equivalent | |
| K133991 | ISY | DZE | Substantially Equivalent | |
| K113779 | CONELOG IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K103252 | CAMLOG VARIO SR ABUTMENTS | NHA | Substantially Equivalent | |
| K090347 | CAMLOG ABUTMENTS PS | NHA | Substantially Equivalent | |
| K083496 | CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS | DZE | Substantially Equivalent | |
| K073553 | CAMLOG IMPLANT SYSTEM ABUTMENTS | NHA | Substantially Equivalent | |
| K071213 | CAMLOG LOGFIT PROSTHETIC SYSTEM | NHA | Substantially Equivalent | |
| K051636 | CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES | NHA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613866 | 3002806355 | ALTATEC GMBH | MAYBACHSTRASSE 5, WIMSHEIM Baden-Wurttemberg D-71299 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain