Discus Dental LLC

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
15
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0425-2015Class IIRelief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately inOctober 24, 2014
Z-1186-2013Class IISL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CAJuly 21, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K102639SL3December 1, 2010
K101612ZEN CORDLESS PROPHY SYSTEMJune 30, 2010
K101215NUANCEMay 12, 2010
K093208SIMPLISEALFebruary 12, 2010
K092417INSIGHT ULTRASONIC INSERTSDecember 11, 2009
K073518FLASHLITE REBEL*December 20, 2007
K062176RELIEF ACP ORAL CARE GELJanuary 10, 2007
K052090SPLASH! IMPRESSION MATERIAL DEVICEAugust 5, 2005
K051776PROTEGE ULTRASONIC INSERTJuly 13, 2005
K033785PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDEJune 18, 2004
K040053PRECISION VPS IMPRESSION MATERIALMarch 25, 2004
K033381DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT,January 27, 2004
K030776MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIALMay 9, 2003
K023748FLASH-LITE II LED DENTAL CURING LIGHTJanuary 17, 2003
K022184FLASH-LITE LED DENTAL CURING LIGHTAugust 20, 2002