Friadent GmbH: FDA clearances and approvals
Friadent GmbH has 18 FDA 510(k) clearances (first 1999, latest 2004), across 3 product codes in 1 review panel. Median 510(k) review time: 80 days.
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 | 16 | 16 |
| KMW | Handpiece, Rotary Bone Cutting | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
Review panels
- Dental (18)
Most recent Friadent GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040170 | FRIADENT PLUS DENTAL IMPLANT SYSTEMS | DZE | 2004-10-27 | 275 |
| K041509 | ANKYLOS DENTAL IMPLANT SYSTEM | DZE | 2004-08-26 | 80 |
| K040946 | ANKYLOS DENTAL IMPLANT SYSTEM | DZE | 2004-07-01 | 80 |
| K032302 | XIVE TG ABUTMENTS | DZE | 2003-10-02 | 69 |
| K032284 | XIVE TG DENTAL IMPLANT SYSTEM | DZE | 2003-08-14 | 21 |
| K032158 | XIVE DENTAL IMPLANT SYSTEM MULTIPLE | DZE | 2003-08-14 | 30 |
| K031674 | MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM | DZE | 2003-08-14 | 76 |
| K024004 | XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM | DZE | 2003-03-03 | 89 |
| K023799 | FRIOS ALGIPORE | LYC | 2003-02-05 | 83 |
| K021318 | XIVE DENTAL IMPLANT SYSTEM | DZE | 2002-07-02 | 68 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Friadent GmbH.
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 Friadent GmbH have?
Friadent GmbH has 18 FDA 510(k) clearances (first 1999, latest 2004), across 3 product codes in 1 review panel.
How long does FDA take to clear Friadent GmbH's 510(k)s?
The median time from FDA receipt to decision across Friadent GmbH's cleared 510(k)s is 80 days.
What devices does Friadent GmbH make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 16); KMW (Handpiece, Rotary Bone Cutting, 1); LYC (Bone Grafting Material, Synthetic, 1).
Has Friadent GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Friadent GmbH. Related entities may recall under other names.
Next steps
- See all 18 Friadent GmbH clearances with predicates and recalls
- Run predicate analysis for product code DZE, Friadent GmbH'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.