Medentika GmbH: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Medentika GmbH” (first 2015, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 218 days. Since 2017 the median was 216 days, against 191 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2015 | 2 | 232 |
| 2016 | 0 | — |
| 2017 | 1 | 178 |
| 2018 | 0 | — |
| 2019 | 1 | 308 |
| 2020 | 3 | 193 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 560 |
| 2025 | 2 | 162 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medentika GmbH took a median 216 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 9 | 9 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
Review panels
- Dental (10)
Most recent Medentika GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253341 | Custom Abutments AS | NHA | 2025-12-23 | 84 |
| K242542 | Medentika CAD/CAM Abutments | NHA | 2025-04-22 | 239 |
| K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments | NHA | 2024-04-15 | 560 |
| K201711 | CARES Screw - Retained Bars and Bridges (SRBB) | NHA | 2020-12-08 | 168 |
| K200906 | MINICONE Implant | DZE | 2020-10-16 | 193 |
| K191123 | Multi-unit Abutments | NHA | 2020-01-06 | 252 |
| K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases | NHA | 2019-01-07 | 308 |
| K170838 | Medentika CAD/CAM TiBases | NHA | 2017-09-15 | 178 |
| K150203 | Medentika CAD/CAM Abutments | NHA | 2015-10-23 | 267 |
| K142167 | MEDENTIKA ABUTMENT SYSTEM | NHA | 2015-02-20 | 198 |
Recalls
openFDA lists no recalls under a recalling firm named Medentika GmbH.
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 Medentika GmbH?
FDA lists 10 510(k) clearances under the applicant name “Medentika GmbH” (first 2015, latest 2025), across 2 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 Medentika GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medentika GmbH is 218 days. Since 2017: 216 days, versus 191 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medentika GmbH?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 9); DZE (Implant, Endosseous, Root-Form, 1).
Next steps
- See all 10 Medentika GmbH clearances with predicates and recalls
- Run predicate analysis for product code NHA, Medentika GmbH'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.