Manufacturer registered with FDA
ACURATA GMBH & CO. KGaA
Thurmansbang, Germany. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Germany
Registered in 2 markets
Where regulators' registries name ACURATA GMBH & CO. KGaA 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 | ACURATA GMBH & CO. KGaA | 4 device types | — | Below |
| European Union | EUDAMED | Manufacturer | acurata GmbH & Co. KGaA | 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 ACURATA GMBH & CO. KGaA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | Acurata | 2015 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | Acurata | 2015 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Acurata | 2015 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | Acurata | 2015 |
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 |
|---|---|---|
| ACURATA GMBH & CO. KGaAFDA reg. 3011302409 | Thurmansbang Bavaria, Germany | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049065). 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.