Dreve Dentamid GmbH
UNNA North Rhine-Westphalia, DE
DREVE DENTAMID GMBH appears in FDA device records in UNNA North Rhine-Westphalia, DE. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Dreve Dentamid GmbH between 2017 and 2025. The busiest year on record is 2018, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250739 | Primeprint Direct Aligner | NXC | Substantially Equivalent | |
| K200580 | FotoDent denture | EBI | Substantially Equivalent | |
| K190571 | StoneBite and StoneBite scan | ELW | Substantially Equivalent | |
| K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | ELW | Substantially Equivalent | |
| K162408 | Nano Varnish, Plaquit, Lightpaint on Surface | EBD | Substantially Equivalent | |
| K171729 | Fixtemp C&B | EBG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000486347 | 1000486347 | DREVE DENTAMID GMBH | MAX-PLANCK-STR. 31, UNNA North Rhine-Westphalia 59423 DE | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NDPAccessories, Implant, Dental, Endosseous
- NXCAligner, Sequential
- EMACement, Dental
- EBDCoating, Filling Material, Resin
- EBGCrown And Bridge, Temporary, Resin
- ELWMaterial, Impression
- EBHMaterial, Impression Tray, Resin
- EEAPlate, Base, Shellac
- KMYPositioner, Tooth, Preformed
- EBIResin, Denture, Relining, Repairing, Rebasing
- EIDSyringe, Restorative And Impression Material
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain