Nobel Biocare USA, LLC: FDA clearances and approvals
Nobel Biocare USA, LLC has 9 FDA 510(k) clearances (first 2005, latest 2014), across 3 product codes in 1 review panel. Median 510(k) review time: 71 days. openFDA lists 68 product recalls by a recalling firm named Nobel Biocare USA, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 236 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 6 | 6 |
| DZE | Implant, Endosseous, Root-Form | 2 | 2 |
| EIH | Powder, Porcelain | 1 | 1 |
Review panels
- Dental (9)
Most recent Nobel Biocare USA, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132749 | NOBELPROCERA OVERDENTURE BAR | NHA | 2014-07-24 | 324 |
| K132746 | NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION | NHA | 2014-01-30 | 149 |
| K110171 | NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS | NHA | 2011-06-15 | 146 |
| K083100 | GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP | NHA | 2008-11-19 | 30 |
| K073142 | NOBELREPLACE HEXAGONAL IMPLANT | DZE | 2008-01-11 | 65 |
| K062566 | NOBELREPLACE TAPERED CONICAL CONNECTION | DZE | 2006-12-06 | 97 |
| K052885 | ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 | NHA | 2005-12-23 | 71 |
| K050641 | ZYGOMA TIUNITE | NHA | 2005-04-07 | 24 |
| K043312 | NOBELRONDO DENTAL CERAMIC - ZIRCONIA | EIH | 2005-02-01 | 62 |
Recalls
68 product recalls in 14 recall events; 1 initiated in the last five years. Most recent: 2021-12-17.
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 USA, LLC have?
Nobel Biocare USA, LLC has 9 FDA 510(k) clearances (first 2005, latest 2014), across 3 product codes in 1 review panel.
How long does FDA take to clear Nobel Biocare USA, LLC's 510(k)s?
The median time from FDA receipt to decision across Nobel Biocare USA, LLC's cleared 510(k)s is 71 days.
What devices does Nobel Biocare USA, LLC make?
Its most frequent FDA product codes are NHA (Abutment, Implant, Dental, Endosseous, 6); DZE (Implant, Endosseous, Root-Form, 2); EIH (Powder, Porcelain, 1).
Has Nobel Biocare USA, LLC had device recalls?
openFDA lists 68 product recalls in 14 recall events by a recalling firm whose name matches Nobel Biocare USA, LLC; the most recent began 2021-12-17. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 9 Nobel Biocare USA, LLC clearances with predicates and recalls
- Run predicate analysis for product code NHA, Nobel Biocare USA, LLC'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.