Not currently registered with FDA under this name

Sultan Dental Products, Ltd.

Englewood, NJ, United States. Named as applicant on 1 dental 510(k) clearance between 2000 and 2000. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12000–2000
Markets registered in
22 registrations outside the US
Establishments
0—
2000: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 2 markets

Where regulators' registries name Sultan Dental Products, Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesSouth Korea: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantSultan Dental Products, Ltd.1 clearances2000–2000Below
South KoreaMFDSManufacturerSultan Dental Products, Ltd.Sultan Dental products,Ltd.22000–2000Pure 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 Sultan Dental Products, Ltd. as the applicant.

Decided510(k)DeviceDevice type
20 Oct 2000K002581DURAGARD SODIUM FLUORIDE VARNISHLBH Cavity Varnish

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.