Manufacturer registered with FDA
frasaco GmbH
TETTNANG, Germany. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 312 registrations outside the US
- Establishments
- 1Germany
Registered in 3 markets
Where regulators' registries name frasaco 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 | frasaco GmbH | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | FRASACO GMBHFRASACO Gmbh | 10 | 2012–2022 | Pure Global AI |
| Australia | TGA | Manufacturer | frasaco GmbH | 2 | 2020–2020 | 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 frasaco 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | MATRIX BANDS | 1996 |
| Preformed CrownELZ · Class 1 | — | Maker | STRIP CROWN FORMS | 1996 |
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 |
|---|---|---|
| FRASACO GMBHFDA reg. 8010339 | TETTNANG Baden-Wurttemberg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9032384). 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.