# Rolence Ent., Inc.

- Location (FDA's records): Chungli, TW
- FDA decisions: 5 (2002–2009): 5 510(k) clearances
- Product codes: EBZ (4), EFB (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 3 (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
- Jindell Medical Instruments Co., Ltd.: 1 (https://510kreport.com/company/jindell-medical-instruments)

## Firms that cite its devices most
- Apoza Enterprise Co., Ltd.: 1 (https://510kreport.com/company/apoza-enterprise)
- Delma Medical Instrument (Guangzhou) Co., Ltd.: 1 (https://510kreport.com/company/delma-medical-instrument-guangzhou)
- Beyes Dental Canada, Inc.: 1 (https://510kreport.com/company/beyes-dental-canada)

## Its most-cited devices
- K093084: Rolence Dental High Speed Handpiece, RHP (2009), cited by 2
- K023545: Ultra-Lite 200E Light Cure Unit (2002), cited by 1

## Recent decisions
- K093084: Rolence Dental High Speed Handpiece, RHP (Dec 16, 2009)
- K023545: Ultra-Lite 200E Light Cure Unit (Dec 30, 2002)
- K020874: Ultra-Lite 5 Turbo Light Cure Unit (Jun 12, 2002)
- K020884: Excellite Light Cure Unit (Jun 12, 2002)
- K020877: Excellite Turbo Light Cure Unit (Jun 12, 2002)

Source page: https://510kreport.com/company/rolence-ent