# Unitek Corp.

- Location (FDA's records): Monrovia, CA
- FDA decisions: 23 (1980–1994): 23 510(k) clearances
- Product codes: EJF (4), EJS (3), JEX (3), DYW (2), ECI (2), DYH (2), DYT (1), EJT (1), EID (1), EKM (1), DYN (1), EBZ (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 11 (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 that cite its devices most
- Ortho Organizers, Inc.: 2 (https://510kreport.com/company/ortho-organizers)
- 3M Unitek: 2 (https://510kreport.com/company/3m-unitek)
- American Orthodontics: 1 (https://510kreport.com/company/american-orthodontics)
- Reliance Orthodontic Products, Inc.: 1 (https://510kreport.com/company/reliance-orthodontic-products)
- Dentscare Ltda: 1 (https://510kreport.com/company/dentscare)
- Largent Health, LLC: 1 (https://510kreport.com/company/largent-health)
- Young O/S, LLC: 1 (https://510kreport.com/company/young-o-s)
- Ormco Corp.: 1 (https://510kreport.com/company/ormco)

## Its most-cited devices
- K880393: Transbond Light Cured Orthodontic Adhesive (1988), cited by 6
- K944286: Metal-Lined Transcend Ceramic Bracket (1994), cited by 2
- K861965: Unitek Ceramic Bracket System (1986), cited by 1
- K832654: Heated Gutta Percha Delivery System (1983), cited by 1
- K911271: Adhesive Precoated Brackets (1991), cited by 1

## Recent decisions
- K944286: Metal-Lined Transcend Ceramic Bracket (Nov 29, 1994)
- K933501: Alastik (Apr 28, 1994)
- K940165: Alastik (Mar 7, 1994)
- K923999: Alastik NS (Jun 24, 1993)
- K924645: Transcend Series 6000 Debonding Instruments (Nov 25, 1992)
- K924295: Debracketing Instrument (Nov 23, 1992)
- K923432: German Mini Dynalock (Oct 30, 1992)
- K911271: Adhesive Precoated Brackets (May 29, 1991)

Source page: https://510kreport.com/company/unitek