FDA 510(k) Applications Submitted by COLTENE/WHALEDENT INC.

FDA 510(k) Number Submission Date Device Name Applicant
K071632 06/14/2007 PERFECT TISSUE CONTOURING SYSTEM II COLTENE/WHALEDENT INC.
K003034 09/28/2000 COLTENE AURA COMPOMER RESTORATIVE SYSTEM COLTENE/WHALEDENT INC.
K000311 02/01/2000 PARAPOST FIBER WHITE COLTENE/WHALEDENT INC.
K040551 03/02/2004 COLTOLUX LED CURING LIGHT COLTENE/WHALEDENT INC.
K031752 06/05/2003 COLTOSOL F COLTENE/WHALEDENT INC.
K993255 09/28/1999 BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE COLTENE/WHALEDENT INC.
K013400 10/15/2001 SYNERGY FLOW COLTENE/WHALEDENT INC.
K993545 10/19/1999 TENAX WHITE POST COLTENE/WHALEDENT INC.
K983727 10/22/1998 BIOSONIC ULTRASONIC SCALER SYSTEM COLTENE/WHALEDENT INC.
K993710 11/03/1999 MODIFICATION OF PARAPOST CEMENT COLTENE/WHALEDENT INC.
K993835 11/12/1999 PARAPOST SYSTEM STERILIZABLE ORGANIZER COLTENE/WHALEDENT INC.
K974906 12/31/1997 ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM COLTENE/WHALEDENT INC.
K974465 11/26/1997 SYNERGY COLTENE/WHALEDENT INC.
K033760 12/02/2003 ONE COAT SE BOND COLTENE/WHALEDENT INC.
K051660 06/22/2005 DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM COLTENE/WHALEDENT INC.


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