Not currently registered with FDA under this name
Schoelly Fiberoptic GmbH
Newton, MA, United States. Named as applicant on 1 dental 510(k) clearance between 1999 and 1999. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 11999–1999
- Markets registered in
- 430 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 4 markets
Where regulators' registries name Schoelly Fiberoptic GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Schoelly Fiberoptic GmbH | 1 clearances | 1999–1999 | Below |
| Australia | TGA | Manufacturer | Schoelly Fiberoptic GmbH | 11 | 2015–2025 | Pure Global AI |
| China | NMPA | Registration holder | 雪力纤维光学有限公司SCHOELLY FIBEROPTIC GMBH雪力纤维光学有限公司Schoelly Fiberoptic GmbH | 11 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Schoelly Fiberoptic GmbH | 8 | 2012–2024 | 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
Sources
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 of the most recent filing, which can be a US agent.