Nobel Biocare Uas, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Nobel Biocare Uas, Inc.” (first 1997, latest 2005), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Envista (Nobel Biocare, Ormco, Kerr), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 20 | 20 |
| NHA | Abutment, Implant, Dental, Endosseous | 8 | 8 |
| EIH | Powder, Porcelain | 2 | 2 |
| DZI | Drill, Bone, Powered | 1 | 1 |
Review panels
- Dental (31)
Most recent Nobel Biocare Uas, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050444 | NOBELREPLACE ADAPTER, MODEL 32412 | NHA | 2005-07-07 | 135 |
| K042658 | PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 | NHA | 2004-10-20 | 22 |
| K041661 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS | DZE | 2004-08-26 | 69 |
| K041876 | NOBELDIRECT OD IMPLANT | DZE | 2004-08-20 | 39 |
| K041312 | NOBELRONDO DENTAL CERAMIC-ALUMINA | EIH | 2004-07-23 | 67 |
| K041275 | PROCERA ABUTMENT OCTAGON | NHA | 2004-05-27 | 15 |
| K040573 | NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236 | NHA | 2004-04-28 | 55 |
| K033724 | NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236 | NHA | 2004-02-23 | 89 |
| K031345 | NOBEL DIRECT, MODELS 30937, 30938 | DZE | 2003-07-24 | 86 |
| K030257 | NOBEL PERFECT IMPLANT SYSTEM | DZE | 2003-02-10 | 17 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nobel Biocare Uas, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nobel Biocare AB (94 510(k)s)
- Nobel Scientific Industries, Inc. (23 510(k)s)
- Nobel Biocare USA, LLC (9 510(k)s)
- Nobel Biocare Services AG (5 510(k)s)
- Nobel Biocare AG (2 510(k)s)
- Nobel Biocare C/O Medicim NV (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nobel Biocare Uas, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Nobel Biocare Uas, Inc.” (first 1997, latest 2005), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nobel Biocare Uas, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nobel Biocare Uas, Inc. is 86 days.
Which FDA product codes appear under Nobel Biocare Uas, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 20); NHA (Abutment, Implant, Dental, Endosseous, 8); EIH (Powder, Porcelain, 2).
Next steps
- See all 31 Nobel Biocare Uas, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Nobel Biocare Uas, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.