Not currently registered with FDA under this name

Prodrive Systems, Inc.

Spencerville, Ontario, Canada. Named as applicant on 3 dental 510(k) clearances between 2006 and 2009. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
32006–2009
Markets registered in
2117 registrations outside the US
Establishments
0—
2006: 12007: 12009: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 2 markets

Where regulators' registries name Prodrive Systems, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 3 clearancesCanada: 117 registrations
RegisteredHome: CanadaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantProdrive Systems, Inc.3 clearances2006–2009Below
CanadaHealth CanadaRegistration holderPRODRIVE SYSTEMS INC.1172006–2010Pure 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 Prodrive Systems, Inc. as the applicant.

Decided510(k)DeviceDevice type
27 Feb 2009K090369PRODRIVE LINE OF DENTAL HANDPIECESEFB Dental Air-Powered Handpiece
7 Dec 2007K073353DO-ALL DENTAL HANDPIECE LUBRICANTEFB Dental Air-Powered Handpiece
4 Aug 2006K062219PRODRIVE SYSTEMS REPLACEMENT TURBINEEFB Dental Air-Powered 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.