# Ortek Therapeutics, Inc.

- Location (FDA's records): New York, NY
- FDA decisions: 3 (2000–2017): 3 510(k) clearances
- Product codes: NBL (1), EJR (1), LBH (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cariescan, Ltd.: 1 (https://510kreport.com/company/cariescan)
- Pertec of Wisconsin, Inc.: 1 (https://510kreport.com/company/pertec-of-wisconsin)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)

## Firms that cite its devices most
- Colgate-Palmolive Co.: 2 (https://510kreport.com/company/colgate-palmolive)
- Discus Dental, Inc.: 1 (https://510kreport.com/company/discus-dental)
- Usbiomaterials Corp.: 1 (https://510kreport.com/company/usbiomaterials)

## Its most-cited devices
- K002989: Proclude (2000), cited by 3
- K003482: Proclude-Sensitive (2001), cited by 1

## Recent decisions
- K170822: Electronic Caries Detector (Sep 11, 2017)
- K003482: Proclude-Sensitive (Feb 1, 2001)
- K002989: Proclude (Dec 14, 2000)

Source page: https://510kreport.com/company/ortek-therapeutics