Company ยท US
Pac-Dent International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2017. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2017 | K162662 | GingiDent Gingival Retraction Paste Pac-Dent International, Inc. | MVL |
| Jul 25, 2016 | K160577 | PacEndo Chlorhexidine Pac-Dent International, Inc. | KJJ |
| Mar 3, 2016 | K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film Pac-Dent International, Inc. | PEM |
| Feb 1, 2016 | K153528 | PacEndo EDTA Pac-Dent International, Inc. | KJJ |
| Nov 10, 2015 | K151852 | PacEndo Sodium Hyprochlorite Pac-Dent International, Inc. | KJJ |
| Jul 28, 2015 | K151150 | Elements Pac-Dent International, Inc. | ELW |
| Mar 9, 2015 | K141717 | PACSEAL PIT & FISSURE SEALANT Pac-Dent International, Inc. | EBC |
| Sep 30, 2014 | K141422 | PROFLUORO FLUORIDE VARNISH Pac-Dent International, Inc. | LBH |
| Aug 13, 2013 | K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC Pac-Dent International, Inc. | EBF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||