# Tomy, Inc.

- Location (FDA's records): Bradenton, FL
- FDA decisions: 4 (2012–2018): 4 510(k) clearances
- Product codes: NJM (3), DYW (1)
- Predicates its devices cite: 10 (1 its own); citations of its devices by later devices: 3 (1 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
- Dentsply Interntional: 2 (https://510kreport.com/company/dentsply-interntional)
- 3M Unitek: 2 (https://510kreport.com/company/3m-unitek)
- Dentsply International, Inc.: 2 (https://510kreport.com/company/dentsply-international)
- Cdb Corporation: 1 (https://510kreport.com/company/cdb)
- Gestenco International AB: 1 (https://510kreport.com/company/gestenco-international)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)

## Firms that cite its devices most
- Mem Dental Technology Co., Ltd.: 1 (https://510kreport.com/company/mem-dental-technology)
- Signature Orthodontics: 1 (https://510kreport.com/company/signature-orthodontics)

## Its most-cited devices
- K160615: Orthodontic Ceramic Brackets 1.1 (2016), cited by 2
- K123094: Orthodontic Ceramic Brackets (2012), cited by 1

## Recent decisions
- K180718: Orthodontic Plastic Brackets and Accessories (Oct 30, 2018)
- K160615: Orthodontic Ceramic Brackets 1.1 (Aug 26, 2016)
- K123092: Ceramin Brackets Z (Dec 21, 2012)
- K123094: Orthodontic Ceramic Brackets (Dec 13, 2012)

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