Nobel Biocare AB: FDA clearances and approvals
Nobel Biocare AB has 94 FDA 510(k) clearances (first 2002, latest 2026), across 10 product codes in 4 review panels. Median 510(k) review time: 116 days. Since 2017 its median was 180 days, against 151 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 198 |
| 2014 | 2 | 152 |
| 2015 | 1 | 270 |
| 2016 | 9 | 180 |
| 2017 | 9 | 191 |
| 2018 | 6 | 163 |
| 2019 | 3 | 225 |
| 2020 | 4 | 94 |
| 2021 | 0 | — |
| 2022 | 1 | 136 |
| 2023 | 3 | 163 |
| 2024 | 1 | 118 |
| 2025 | 2 | 294 |
| 2026 | 3 | 234 |
Review time against the same product codes
Since 2017, Nobel Biocare AB's cleared 510(k)s took a median 180 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 151 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 42 | 42 |
| DZE | Implant, Endosseous, Root-Form | 30 | 30 |
| LLZ | System, Image Processing, Radiological | 8 | 8 |
| ELL | Teeth, Porcelain | 5 | 5 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 4 | 4 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| MYN | Analyzer, Medical Image | 1 | 1 |
| PNP | Dental Abutment Design Software For Dental Laboratory | 1 | 1 |
Review panels
- Dental (80)
- Radiology (9)
- General Hospital (4)
- General and Plastic Surgery (1)
Most recent Nobel Biocare AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253988 | LiteSet Trays | KCT | 2026-09-08 | 270 |
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | NHA | 2026-08-06 | 234 |
| K252197 | Nobel Biocare S Series Implants | DZE | 2026-02-18 | 219 |
| K243834 | NobelZygoma TiUltra Implant system | DZE | 2025-08-25 | 255 |
| K240346 | NobelProcera Zirconia Implant Bridge | NHA | 2025-01-03 | 333 |
| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | NHA | 2024-01-24 | 118 |
| K231898 | DTX Studio Clinic (4.0) | LLZ | 2023-12-08 | 163 |
| K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | NHA | 2023-04-28 | 141 |
| K221921 | DTX Studio Clinic 3.0 | MYN | 2023-03-28 | 270 |
| K213562 | DTX Studio Clinic 3.0 | LLZ | 2022-03-25 | 136 |
84 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nobel Biocare AB.
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 AB have?
Nobel Biocare AB has 94 FDA 510(k) clearances (first 2002, latest 2026), across 10 product codes in 4 review panels.
How long does FDA take to clear Nobel Biocare AB's 510(k)s?
The median time from FDA receipt to decision across Nobel Biocare AB's cleared 510(k)s is 116 days. Since 2017: 180 days, versus 151 days for all cleared 510(k)s in the same product codes.
What devices does Nobel Biocare AB make?
Its most frequent FDA product codes are NHA (Abutment, Implant, Dental, Endosseous, 42); DZE (Implant, Endosseous, Root-Form, 30); LLZ (System, Image Processing, Radiological, 8).
Has Nobel Biocare AB had device recalls?
openFDA lists no recalls under a recalling firm name matching Nobel Biocare AB. Related entities may recall under other names.
Next steps
- See all 94 Nobel Biocare AB clearances with predicates and recalls
- Run predicate analysis for product code NHA, Nobel Biocare AB'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.