Not currently registered with FDA under this name

Ortek Therapeutics, Inc.

Roslyn Heights, NY, United States. Named as applicant on 3 dental 510(k) clearances between 2000 and 2017. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 32000–2017
Markets registered in: 1United States
Establishments: 0—

510(k) clearances per year, 2000–2026

510(k) clearances

Clearances on which FDA names Ortek Therapeutics, Inc. as the applicant.

Decided	510(k)	Device	Device type
11 Sep 2017	K170822	Electronic Caries Detector	NBL Light-Induced Fluorescence Caries Detector
1 Feb 2001	K003482	PROCLUDE-SENSITIVE	LBH Cavity Varnish
14 Dec 2000	K002989	PROCLUDE	EJR Oral Cavity Abrasive Polishing Agent

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.