Medical Device Manufacturer · US , New York , NY

Ortek Therapeutics, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2000

Recent clearances: Electronic Caries Detector, PROCLUDE-SENSITIVE, PROCLUDE

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ortek Therapeutics, Inc. Dental ✕

3 devices

1-3 of 3

Cleared Sep 11, 2017

Electronic Caries Detector

Cleared Feb 01, 2001

PROCLUDE-SENSITIVE

Cleared Dec 14, 2000

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 14, 2026