Dental Device Guide
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Not currently registered with FDA under this name

Dontech Products B.V.

Gorinchem, Zh, Netherlands. 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
1United States
Establishments
0—
2000: 1200020102020

510(k) clearances per year, 2000–2026

510(k) clearances

Clearances on which FDA names Dontech Products B.V. as the applicant.

Decided510(k)DeviceDevice type
11 Feb 2000K993224T-GEAR, MODEL TG/400-700DZB Orthodontic Extraoral Headgear

Some of these clearances are listed with FDA today by another company: Rmo, Inc. (1).

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.