Manufacturer registered with FDA
zebris Medical GmbH
Isny, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 414 registrations outside the US
- Establishments
- 1Germany
Registered in 4 markets
Where regulators' registries name zebris Medical 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 | zebris Medical GmbH | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | zebris Medical GmbHZebris Medical GmbH | 6 | 2009–2020 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ZEBRIS MEDICAL GMBH | 5 | 2008–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | zebris Medical GmbHZebris Medical GmbH | 3 | — | 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 zebris Medical 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 |
|---|---|---|---|---|
| Jaw Tracking Device for Monitoring Jaw PositionsNFS · Class 1 | — | Maker | Accessories: Alignment Spoon; Paraocclusal Attachment; Paraocclusal Attachment with Lip Arch;Accessories: Occlusal Attachment UN; Bite Fork UN; Bite Fork Adapter UN; Bite Fork PS1; Fusion Bite; Fusion Bite AdapterJMA-OpticJMA-Optic AG "zebris for ceramill"JMAnalyser+JMT+,PlaneAnalyser II | 2005 |
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 |
|---|---|---|
| ZEBRIS MEDICAL GMBHFDA reg. 3004982293 | Isny Baden-Wurttemberg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9069902). 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.