Biodenta Swiss AG: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Biodenta Swiss AG” (first 2010, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 157 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 4 | 166 |
| 2014 | 1 | 175 |
| 2015 | 2 | 173 |
| 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 | 5 | 5 |
| NHA | Abutment, Implant, Dental, Endosseous | 5 | 5 |
| EIH | Powder, Porcelain | 1 | 1 |
Review panels
- Dental (11)
Most recent Biodenta Swiss AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151295 | Biodenta Customized Abutment - Titanium | NHA | 2015-12-01 | 200 |
| K150296 | Biodenta Customized Abutment-Hybrid | NHA | 2015-07-02 | 146 |
| K133884 | BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM | DZE | 2014-06-13 | 175 |
| K123491 | BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT | NHA | 2013-05-30 | 198 |
| K122559 | BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS | NHA | 2013-05-03 | 254 |
| K123512 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM | DZE | 2013-03-28 | 135 |
| K123415 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED | DZE | 2013-03-19 | 134 |
| K111003 | BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL | DZE | 2011-09-15 | 157 |
| K110778 | BIODENTA CUSTOMIZED ABUTMENT | NHA | 2011-07-29 | 130 |
| K093630 | BIODENTA DENTAL IMPLANT SYSTEM | DZE | 2010-06-03 | 192 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biodenta Swiss AG.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biodenta Swiss AG?
FDA lists 11 510(k) clearances under the applicant name “Biodenta Swiss AG” (first 2010, latest 2015), across 3 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 Biodenta Swiss AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biodenta Swiss AG is 157 days.
Which FDA product codes appear under Biodenta Swiss AG?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 5); NHA (Abutment, Implant, Dental, Endosseous, 5); EIH (Powder, Porcelain, 1).
Next steps
- See all 11 Biodenta Swiss AG clearances with predicates and recalls
- Run predicate analysis for product code DZE, Biodenta Swiss AG'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.