# Opusdent, Ltd.

- Location (FDA's records): Ra'Ananna, IL
- FDA decisions: 5 (2000–2002): 5 510(k) clearances
- Product codes: GEX (5)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 11 (4 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
- American Dental Technologies, Inc.: 2 (https://510kreport.com/company/american-dental-technologies)
- Biolase Technology, Inc.: 2 (https://510kreport.com/company/biolase-technology)
- Kavo America: 1 (https://510kreport.com/company/kavo-america)
- Buckman Co., Inc.: 1 (https://510kreport.com/company/buckman)
- Medart Corp.: 1 (https://510kreport.com/company/medart)

## Firms that cite its devices most
- Msq (M2), Ltd.: 2 (https://510kreport.com/company/msq-m2)
- Ivoclar Vivadent, Inc.: 1 (https://510kreport.com/company/ivoclar-vivadent)
- Fotona D.D.: 1 (https://510kreport.com/company/fotona-dd)
- Lumenis, Inc.: 1 (https://510kreport.com/company/lumenis)
- Light Instruments: 1 (https://510kreport.com/company/light-instruments)
- Lutronic Corporation: 1 (https://510kreport.com/company/lutronic)

## Its most-cited devices
- K000990: Opus 10 Dental Diode Laser (2000), cited by 3
- K011769: Opus 10 (with Tooth Whitening Application), Model 2ND (2001), cited by 3
- K021508: Opusduo EC Dental Laser System (2002), cited by 2
- K002899: Opus 20, Model 1ST (2000), cited by 2
- K014100: Opus Spectrum (a Model of Opus 20), Model 2ND (2002), cited by 1

## Recent decisions
- K021508: Opusduo EC Dental Laser System (Aug 7, 2002)
- K014100: Opus Spectrum (a Model of Opus 20), Model 2ND (Jan 8, 2002)
- K011769: Opus 10 (with Tooth Whitening Application), Model 2ND (Aug 30, 2001)
- K002899: Opus 20, Model 1ST (Dec 12, 2000)
- K000990: Opus 10 Dental Diode Laser (Jun 23, 2000)

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