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FDA 510(k) Applications Submitted by KAREN KAKUNES
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190627
03/12/2019
VALO Grand Corded
Ultradent Products, Inc.
K151094
04/23/2015
Mosaic Universal Composite
ULTRADENT PRODUCTS, INC.
K201795
06/30/2020
Transcend
Ultradent Product, Inc.
K132109
07/08/2013
ENAMELAST
ULTRADENT PRODUCTS INC. / ORATECH LLC
K123215
10/15/2012
VISCOSTAT CLEAR
ULTRADENT PRODUCTS, INC.
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