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FDA 510(k) Applications Submitted by Coltene/Whaledent AG
FDA 510(k) Number
Submission Date
Device Name
Applicant
K181500
06/07/2018
BRILLIANT Crios
Coltene/Whaledent AG
K052820
10/04/2005
PARAPOST PARACORE AUTOMIX 5ML
COLTENE/WHALEDENT AG
K050013
01/03/2005
RETRACTOFOAM
COLTENE/WHALEDENT AG
K050426
02/18/2005
TEMPOSIL, MODEL 6720
COLTENE/WHALEDENT AG
K051243
05/13/2005
JET BLUE BITE
COLTENE/WHALEDENT AG
K072604
09/17/2007
DUO TEMP
COLTENE/WHALEDENT AG
K053040
10/27/2005
PARACEM UNIVERSAL DC
COLTENE/WHALEDENT AG
K083304
11/10/2008
TEMPOSIL 2
COLTENE/WHALEDENT AG
K112168
07/28/2011
COMPONEER
COLTENE/WHALEDENT AG
K150218
01/30/2015
Fill-Up!
COLTENE/WHALEDENT AG
K160800
03/23/2016
DuoCem
COLTENE/WHALEDENT AG
K121621
06/01/2012
SOLOCEM
COLTENE/WHALEDENT AG
K152243
08/10/2015
One Coat 7 Universal
Coltene/Whaledent AG
K152927
10/05/2015
BRILLIANT EVERGLOW
COLTENE/WHALEDENT AG
K190597
03/07/2019
BRILLIANT EverGlow Flow
Coltene/Whaledent AG
K191385
05/23/2019
BRILLIANT COMPONEER
Coltene/Whaledent AG
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