Coltene/Whaledent, Inc.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K071632	PERFECT TISSUE CONTOURING SYSTEM II	EKZ	2007-10-18	View
510(k)	K051660	DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM	KMH	2005-08-04	View
510(k)	K040551	COLTOLUX LED CURING LIGHT	EBZ	2004-03-15	View
510(k)	K033760	ONE COAT SE BOND	KLE	2004-01-23	View
510(k)	K031752	COLTOSOL F	EMA	2003-08-05	View
510(k)	K013400	SYNERGY FLOW	EBF	2001-12-10	View
510(k)	K003034	COLTENE AURA COMPOMER RESTORATIVE SYSTEM	EBF	2000-11-30	View
510(k)	K993545	TENAX WHITE POST	ELR	2000-04-14	View
510(k)	K000311	PARAPOST FIBER WHITE	ELR	2000-03-14	View
510(k)	K993710	MODIFICATION OF PARAPOST CEMENT	EMA	1999-12-21	View
510(k)	K993835	PARAPOST SYSTEM STERILIZABLE ORGANIZER	FRG	1999-12-16	View
510(k)	K993255	BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE	FRG	1999-12-06	View
510(k)	K983727	BIOSONIC ULTRASONIC SCALER SYSTEM	ELC	1999-01-20	View
510(k)	K974906	ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM	KLE	1998-03-24	View
510(k)	K974465	SYNERGY	EBF	1998-03-09	View
510(k)	K945698	COLTOLUX 3, COLTOLUX 4	EBZ	1995-05-24	View
510(k)	K950106	COLTOLUX LIGHT METER	EBZ	1995-05-24	View
510(k)	K945366	PARAPOST CEMENT	EMA	1995-02-02	View
510(k)	K934192	PARAPOST XT SYSTEM	ELR	1994-06-06	View
510(k)	K922615	COLTENE A.R.T. BOND	KLE	1992-08-03	View