Den Tek Oral Care, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K151149 | Ready-Fit | September 30, 2015 |
| K130186 | DENTEK EASY BRUSH WITH FLUORIDE | July 15, 2013 |
| K123849 | NEW COMFORT-FIT DENTAL GUARD | January 10, 2013 |
| K091660 | CUSTOM COMFORT NIGHTGUARD VERSION 2 | June 12, 2009 |
| K083400 | CUSTOM COMFORT NIGHTGUARD | December 11, 2008 |
| K081669 | IMPROVED COMFORT-FIT NIGHTGUARD | July 10, 2008 |
| K072147 | DEN TEK COMFORT FIT NIGHTGUARD | August 30, 2007 |
| K063483 | DEN TEK NIGHTGUARD | January 23, 2007 |