Not currently registered with FDA under this name

Denplus, Inc.

Longueuil, Quebec, Canada. Named as applicant on 2 dental 510(k) clearances between 1999 and 2001. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
21999–2001
Markets registered in
225 registrations outside the US
Establishments
0—
1999: 12001: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 2 markets

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

All markets
United States: 2 clearancesCanada: 25 registrations
RegisteredHome: CanadaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantDenplus, Inc.2 clearances1999–2001Below
CanadaHealth CanadaRegistration holderDENPLUS INCDENPLUS INC.252000–2024Pure 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 Denplus, Inc. as the applicant.

Decided510(k)DeviceDevice type
23 Aug 2001K011762HI-WAVE; POUR-PLUSEBI Rebasing Repairing Relining Denture Resin
8 Sep 1999K991996IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIREBI Rebasing Repairing Relining Denture Resin

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.