Discus Dental LLC
FDA Regulatory Profile
Discus Dental LLC appears in FDA public data with 2 recalls, 15 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0425-2015, Class II) was initiated on October 24, 2014. Its most recent 510(k) clearance was granted on December 1, 2010.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 15
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0425-2015 | Class II | Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in | October 24, 2014 |
| Z-1186-2013 | Class II | SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA | July 21, 2011 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K102639 | SL3 | December 1, 2010 |
| K101612 | ZEN CORDLESS PROPHY SYSTEM | June 30, 2010 |
| K101215 | NUANCE | May 12, 2010 |
| K093208 | SIMPLISEAL | February 12, 2010 |
| K092417 | INSIGHT ULTRASONIC INSERTS | December 11, 2009 |
| K073518 | FLASHLITE REBEL* | December 20, 2007 |
| K062176 | RELIEF ACP ORAL CARE GEL | January 10, 2007 |
| K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | August 5, 2005 |
| K051776 | PROTEGE ULTRASONIC INSERT | July 13, 2005 |
| K033785 | PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE | June 18, 2004 |
| K040053 | PRECISION VPS IMPRESSION MATERIAL | March 25, 2004 |
| K033381 | DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, | January 27, 2004 |
| K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | May 9, 2003 |
| K023748 | FLASH-LITE II LED DENTAL CURING LIGHT | January 17, 2003 |
| K022184 | FLASH-LITE LED DENTAL CURING LIGHT | August 20, 2002 |