Manufacturer registered with FDA
dentona AG
Dortmund, Germany. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 17
- 510(k) clearances
- 0as applicant
- Markets registered in
- 693 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name dentona AG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | dentona AG | 4 device types | — | Below |
| European Union | EUDAMED | Manufacturer | dentona AG | 70 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | dentona AGdentona AG. | 16 | 2007–2019 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENTONA AG | 3 | 2025–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | dentona AG | 2 | 2019–2020 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | dentona AG | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What dentona AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | dentona flexisplintdentona vivapinkdentona vivatempoptimill memopinkoptimill memosplintoptimill memosplint Soptiprint claraoptiprint durotecoptiprint durotec 405optiprint interim 1 moreoptiprint splint 385 | 2019 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | optiprint tray 385optiprint tray HR | 2019 |
| Backing and Facing Artificial TeethELK · Class 1 | — | Maker | optiprint I-B-T 385optiprint lumina | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | optiprint guide 385optiprint guide 405 | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTONA AGFDA reg. 3009815428 | Dortmund North Rhine-Westphalia, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059705). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.