Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Altatec GmbH — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
298 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | Altatec GmbH | 2020-09-29 | 298 | 0 |
| K160784 | CAM Titanium Blanks | Altatec GmbH | 2016-09-14 | 176 | 0 |
| K153779 | Abutment for Bridges | Altatec GmbH | 2016-03-31 | 91 | 0 |
| K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations | Altatec GmbH | 2016-01-12 | 132 | 0 |
| K151599 | iSy Implant System | Altatec GmbH | 2015-10-02 | 112 | 0 |
| K143337 | CONELOG Titanium base CAD/CAM | Altatec GmbH | 2015-02-17 | 89 | 0 |
| K133991 | ISY | Altatec GmbH | 2014-08-06 | 223 | 0 |
| K113779 | CONELOG IMPLANT SYSTEM | Altatec GmbH | 2012-12-14 | 358 | 0 |
| K103252 | CAMLOG VARIO SR ABUTMENTS | Altatec GmbH | 2011-01-10 | 68 | 0 |
| K090347 | CAMLOG ABUTMENTS PS | Altatec GmbH | 2009-06-18 | 127 | 0 |
| K083496 | CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS | Altatec GmbH | 2009-01-30 | 66 | 0 |
| K073553 | CAMLOG IMPLANT SYSTEM ABUTMENTS | Altatec GmbH | 2008-03-05 | 78 | 0 |
| K071213 | CAMLOG LOGFIT PROSTHETIC SYSTEM | Altatec GmbH | 2007-08-10 | 101 | 0 |
| K051636 | CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORI | Altatec GmbH | 2006-02-17 | 242 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda