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-NumberDeviceDate
K151149Ready-FitSeptember 30, 2015
K130186DENTEK EASY BRUSH WITH FLUORIDEJuly 15, 2013
K123849NEW COMFORT-FIT DENTAL GUARDJanuary 10, 2013
K091660CUSTOM COMFORT NIGHTGUARD VERSION 2June 12, 2009
K083400CUSTOM COMFORT NIGHTGUARDDecember 11, 2008
K081669IMPROVED COMFORT-FIT NIGHTGUARDJuly 10, 2008
K072147DEN TEK COMFORT FIT NIGHTGUARDAugust 30, 2007
K063483DEN TEK NIGHTGUARDJanuary 23, 2007