Manufacturer registered with FDA

Filmtech

Brooklyn, NY, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10052300Manufacturer

Device types listed: 1
Brands and models: 1
510(k) clearances: 11996–1996
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 1990–2026

Devices listed with FDA

What Filmtech currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Dental Air-Powered HandpieceEFB · Class 1	Dental handpieces	Maker	BRIXTON	2016

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Filmtech as the applicant.

Decided	510(k)	Device	Device type
24 Oct 1996	K963664	DENTAL HANDPIECE AND ACCESSORY	EFB Dental Air-Powered Handpiece

Registered establishments

Establishment	Location	What it does
FILMTECHFDA reg. 3003266594	Brooklyn, NY, United States	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10052300). 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.