Medical Device Manufacturer · US , Walnut , CA

Pac-Dent International, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2013

Recent clearances: GingiDent Gingival Retraction Paste, PacEndo Chlorhexidine, Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

View 9 510(k) Devices ↓

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pac-Dent International, Inc. Dental ✕

9 devices

1-9 of 9

Cleared Oct 20, 2017

GingiDent Gingival Retraction Paste

Cleared Jul 25, 2016

PacEndo Chlorhexidine

Cleared Mar 03, 2016

Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film

Cleared Feb 01, 2016

Cleared Nov 10, 2015

PacEndo Sodium Hyprochlorite

Cleared Jul 28, 2015

Cleared Mar 09, 2015

PACSEAL PIT & FISSURE SEALANT

Cleared Sep 30, 2014

PROFLUORO FLUORIDE VARNISH

Cleared Aug 13, 2013

OPTIFLOW II FLOWABLE COMPOSITE, LC