Pac-Dent International, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K162662 | GingiDent Gingival Retraction Paste | October 20, 2017 |
| K160577 | PacEndo Chlorhexidine | July 25, 2016 |
| K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | March 3, 2016 |
| K153528 | PacEndo EDTA | February 1, 2016 |
| K151852 | PacEndo Sodium Hyprochlorite | November 10, 2015 |
| K151150 | Elements | July 28, 2015 |
| K141717 | PACSEAL PIT & FISSURE SEALANT | March 9, 2015 |
| K141422 | PROFLUORO FLUORIDE VARNISH | September 30, 2014 |
| K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | August 13, 2013 |