Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentalpoint AG · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180184 | Zeramex(R) XT Dental Implant System, NobelPearl Dental Impla | Dentalpoint AG | 2018-11-16 | 297 | 0 |
| K163043 | Zeramex P6 Dental Implant System | Dentalpoint AG | 2016-11-30 | 30 | 0 |
| K152385 | Zeramex P6 Dental Implant System | Dentalpoint AG | 2016-07-27 | 338 | 0 |
| K133255 | ZERAMEX T AND ZERAMEX PLUS DENTAL IMPLANT SYSTEMS | Dentalpoint AG | 2014-08-12 | 293 | 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