Recall Z-1186-2013— Discus Dental LLC
Class II · Terminated
Class II FDA medical device recall by Discus Dental LLC, initiated 2011-07-21, terminated 2013-04-29. It names one FDA 510(k) clearance: K102639. Product: SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diode laser intended to be used for dental procedures. Reason: The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece..
- Recalling firm
- Discus Dental LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-07-21
- Terminated
- 2013-04-29
- Firm location
- Culver City, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diode laser intended to be used for dental procedures
Reason for recall
The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece.
Data sourced from openFDA. This site is unofficial and independent of the FDA.