Manufacturer registered with FDA
Smart Optics Sensortechnik GmbH
Bochum, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 417 registrations outside the US
- Establishments
- 1Germany
Registered in 4 markets
Where regulators' registries name Smart Optics Sensortechnik 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 | Smart Optics Sensortechnik GmbH | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | smart optics Sensortechnik GmbH | 10 | 2011–2016 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | smart optics Sensortechnik GmbH | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SMART OPTICS SENSORTECHNIK GMBH | 3 | 2016–2021 | 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 Smart Optics Sensortechnik 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 |
|---|---|---|---|---|
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Aadva Lab Scanner 2Aadva Lab Scanner 2+Aadva Lab Scanner 3Ds ProductionDuo ScanFree stage oneFree stage twinMonoScanSmart optics miniVinyl 2 moreVinyl HRVinyl UXD | 2008 |
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 |
|---|---|---|
| SMART OPTICS SENSORTECHNIK GMBHFDA reg. 3007307470 | Bochum North Rhine-Westphalia, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027204). 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.