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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact