Not currently registered with FDA under this name

Integration Diagnostics, Ltd.

Washington, DC, United States. Named as applicant on 2 dental 510(k) clearances between 2001 and 2004. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
22001–2004
Markets registered in
34 registrations outside the US
Establishments
0—
2001: 12004: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 3 markets

Where regulators' registries name Integration Diagnostics, Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 2 clearancesCanada: 3 registrationsSouth Korea: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantIntegration Diagnostics, Ltd.2 clearances2001–2004Below
CanadaHealth CanadaRegistration holderINTEGRATION DIAGNOSTICS AB32001–2001Pure Global AI
South KoreaMFDSManufacturerIntegration Diagnostics AB12002–2002Pure 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 Integration Diagnostics, Ltd. as the applicant.

Decided510(k)DeviceDevice type
26 Feb 2004K033689OSSTELL MENTOR RFAEKX Ac-Powered Direct Drive Handpiece
9 Aug 2001K003714OSSTELL RESONANCE FREQUENCY ANALYZEREKX Ac-Powered Direct Drive Handpiece

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.