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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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