Nobel Biocare Services AG: FDA clearances and approvals
Nobel Biocare Services AG has 5 FDA 510(k) clearances (first 2021, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time: 204 days. Since 2017 its median was 204 days, against 188 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Nobel Biocare Services AG.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 2 | 172 |
| 2022 | 2 | 212 |
| 2023 | 1 | 60 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Nobel Biocare Services AG's cleared 510(k)s took a median 204 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 2 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
Review panels
- Dental (3)
- General Hospital (2)
Most recent Nobel Biocare Services AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231219 | NobelZygoma PureSet Tray | KCT | 2023-06-27 | 60 |
| K220339 | Esthetic Abutments Nobel Biocare N1 | NHA | 2022-09-16 | 221 |
| K220048 | NobelProcera Zirconia N1 Base | NHA | 2022-07-29 | 204 |
| K211109 | N1 TiUltra TCC Implant System | DZE | 2021-12-21 | 251 |
| K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray | KCT | 2021-12-18 | 94 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-07-20.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Nobel Biocare Services AG have?
Nobel Biocare Services AG has 5 FDA 510(k) clearances (first 2021, latest 2023), across 3 product codes in 2 review panels.
How long does FDA take to clear Nobel Biocare Services AG's 510(k)s?
The median time from FDA receipt to decision across Nobel Biocare Services AG's cleared 510(k)s is 204 days. Since 2017: 204 days, versus 188 days for all cleared 510(k)s in the same product codes.
What devices does Nobel Biocare Services AG make?
Its most frequent FDA product codes are KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 2); NHA (Abutment, Implant, Dental, Endosseous, 2); DZE (Implant, Endosseous, Root-Form, 1).
Has Nobel Biocare Services AG had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Nobel Biocare Services AG; the most recent began 2020-07-20. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Nobel Biocare Services AG clearances with predicates and recalls
- Run predicate analysis for product code KCT, Nobel Biocare Services AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.