Manufacturer registered with FDA
MANI Medical Germany GmbH
Rosbach, Germany. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 659 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name MANI Medical Germany GmbH 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 | MANI Medical Germany GmbH | 3 device types | — | Below |
| Canada | Health Canada | Registration holder | MANI MEDICAL GERMANY GMBH | 39 | 2010–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | MANI MEDICAL GERMANY GmbH | 12 | — | Pure Global AI |
| Australia | TGA | Manufacturer | MANI MEDICAL GERMANY GmbH | 4 | 2026–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | MANI MEDICAL GERMANY GmbH | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Mani Medical Germany GmbH | 1 | — | 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 MANI Medical Germany GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Maker | — | 2017 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | — | 2018 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | — | 2014 |
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 |
|---|---|---|
| MANI MEDICAL GERMANY GmbHFDA reg. 3007584711 | Rosbach Hesse, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028076). 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.