Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nobel Biocare Services AG — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
204 daysmedian FDA review time
251 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231219 | NobelZygoma PureSetâ„¢ Tray | Nobel Biocare Services AG | 2023-06-27 | 60 | 0 |
| K220339 | Esthetic Abutments Nobel Biocare N1 | Nobel Biocare Services AG | 2022-09-16 | 221 | 0 |
| K220048 | NobelProcera Zirconia N1 Base | Nobel Biocare Services AG | 2022-07-29 | 204 | 0 |
| K211109 | N1 TiUltra TCC Implant System | Nobel Biocare Services AG | 2021-12-21 | 251 | 2 |
| K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III T | Nobel Biocare Services AG | 2021-12-18 | 94 | 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