Dental Device Guide
Add your company

Not currently registered with FDA under this name

Scholly Fiberoptic GmbH

Denzlingen, Germany. 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
14194 registrations outside the US
Establishments
0—
1999: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 14 markets

Where regulators' registries name Scholly Fiberoptic GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesCanada: 31 registrationsSouth Korea: 25 registrationsEuropean Union: 24 registrationsUnited Kingdom: 21 registrationsBrazil: 19 registrationsTaiwan: 18 registrationsSerbia: 11 registrationsSaudi Arabia: 10 registrationsColombia: 9 registrationsIsrael: 9 registrationsPeru: 9 registrationsChina: 4 registrationsCosta Rica: 4 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantScholly Fiberoptic GmbH1 clearances1999–1999Below
CanadaHealth CanadaRegistration holderSCHÖLLY FIBEROPTIC GMBH312014–2026Pure Global AI
South KoreaMFDSManufacturerScholly Fiberoptic GmbHSCHOLLY FIBEROPTIC GMBH252005–2020Pure Global AI
European UnionEUDAMEDManufacturerSCHÖLLY FIBEROPTIC GMBH24—Pure Global AI
United KingdomMHRAManufacturerSchölly Fiberoptic GmbH21—Pure Global AI
BrazilANVISAManufacturerSCHOLLY FIBEROPTIC GMBHSCHÖLLY FIBEROPTIC GMBH192008–2025Pure Global AI
TaiwanTFDAManufacturerSCHOLLY FIBEROPTIC GMBHSCHÖLLY FIBEROPTIC GMBH182006–2021Pure Global AI
SerbiaALIMSManufacturerSchölly Fiberoptic GmbH112022–2024Pure Global AI
Saudi ArabiaSFDAManufacturerSCHÖLLY FIBEROPTIC GMBHScholly Fiberoptic GMBH10—Pure Global AI
ColombiaINVIMARegistration holderSCHÖLLY FIBEROPTIC GMBH9—Pure Global AI
IsraelAMARManufacturerSCHOLLY FIBEROPTIC GMBHScholly Fiberoptic GmbH · SCHOLLY Fiberoptic GmbH9—Pure Global AI
PeruDIGEMIDManufacturerSCHÖLLY FIBEROPTIC GMBHSCHOLLY FIBEROPTIC GMBH92016–2026Pure Global AI
ChinaNMPARegistration holder雪力纤维光学有限公司SCHÖLLY FIBEROPTIC GMBH4—Pure Global AI
Costa RicaMinisterio de SaludManufacturerSchölly Fiberoptic GmbH4—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

510(k) clearances

Clearances on which FDA names Scholly Fiberoptic GmbH as the applicant.

Decided510(k)DeviceDevice type
9 Feb 1999K984556SCICAN CLASSICEIA Operative Dental Unit

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.