Data / Medical devices / Germany / Dentona AG
Dentona AG: FDA-registered device maker in Dortmund North Rhine-Westphalia, Germany, 1 510(k) clearance
Dentona AG is registered with the FDA (registration 3009815428) in Dortmund North Rhine-Westphalia, Germany. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 21, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009815428
- Address
- Feldbachacker 16, Dortmund North Rhine-Westphalia, Germany, 44149
- Owner or operator
- dentona AG (10059705)
- Roles
- Manufacturer
- First device listed
- February 13, 2019
- Registered through
- 2026
- Brand names listed
- dentona flexisplint, dentona vivapink, dentona vivatemp, optimill memopink, optimill memosplint, optimill memosplint S, optimill memosplnt S, optiprint I-B-T 385 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Teeth, Artificial, Backing And Facing | ELK | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2023 | K222604 | dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S | MQC | Substantially Equivalent | Dentona AG | accessdata.fda.gov |
Compare with other makers
- All makers of Mouthguard, Prescription
- All makers of Teeth, Artificial, Backing And Facing
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Material, Impression Tray, Resin
- All makers of Maintainer, Space Preformed, Orthodontic
Updated April 21, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.