Not currently registered with FDA under this name

Good-Lite Co.

Mchenry, IL, United States. Named as applicant on 1 dental 510(k) clearance between 1984 and 1984. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
11984–1984
Markets registered in
768 registrations outside the US
Establishments
0—
1984: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 7 markets

Where regulators' registries name Good-Lite Co. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesSouth Korea: 48 registrationsAustralia: 7 registrationsEuropean Union: 4 registrationsUnited Kingdom: 4 registrationsTaiwan: 3 registrationsIsrael: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantGood-Lite Co.1 clearances1984–1984Below
South KoreaMFDSManufacturerGood-Lite CompanyGOOD-LITE · Good-Lite · +2482012–2026Pure Global AI
AustraliaTGAManufacturerGoodlite Co72009–2024Pure Global AI
European UnionEUDAMEDManufacturerGood-Lite Company4—Pure Global AI
United KingdomMHRAManufacturerGood-Lite Corporation4—Pure Global AI
TaiwanTFDAManufacturerGOOD-LITE COMPANY32016–2020Pure Global AI
IsraelAMARManufacturerGOOD-LITE CO.Good-Lite Company2—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 Good-Lite Co. as the applicant.

Decided510(k)DeviceDevice type
2 Aug 1984K842515SURGICAL HEADLIGHTEBA Surgical Headlight Light

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.