Not currently registered with FDA under this name

Global Dental Direct, Inc.

Abbotsford, Bc, Canada. Named as applicant on 1 dental 510(k) clearance between 2009 and 2009. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12009–2009
Markets registered in: 21 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 2 markets

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

All markets

RegisteredHome: CanadaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Global Dental Direct, Inc.	1 clearances	2009–2009	Below
Canada	Health Canada	Registration holder	GLOBAL DENTAL DIRECT	1	2009–2009	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 Global Dental Direct, Inc. as the applicant.

Decided	510(k)	Device	Device type
29 Sep 2009	K092851	MODEL GDCH-2000	EIA Operative Dental Unit

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.