Manufacturer registered with FDA
ModJaw SAS
VILLEURBANNE, France. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 11
- 510(k) clearances
- 0as applicant
- Markets registered in
- 58 registrations outside the US
- Establishments
- 1France
Registered in 5 markets
Where regulators' registries name ModJaw SAS 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 | ModJaw SAS | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | ModJaw | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | ModJaw SAS | 2 | 2024–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | MODJAW | 1 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MODJAW S.A.S | 1 | 2025–2025 | 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 ModJaw SAS 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 | Fiducials (x36)Forks (x20)Frontal tracker (x1)Kit patientMandibular tracker (x1)Pen tracker (x1)Rear band (x1)Tech in MotionTech In Motion USTIMA US 1 moreTwin In Motion | 2018 |
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 |
|---|---|---|
| MODJAWFDA reg. 3014644422 | VILLEURBANNE Rhone, France | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058233). 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.