Cosmedent, Inc.

FDA 510(k) & PMA Approved Devices — 28 products

Total Devices28

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K240714	Insure® Universal; Insure® Universal Automix	EMA	2024-07-24	View
510(k)	K222435	Renamel® Microhybrid ;Renamel® Flowable Microhybrid	EBF	2022-10-11	View
510(k)	K211259	Renamel Bulkfill	EBF	2021-06-24	View
510(k)	K172707	Renamel Microfill	EBF	2017-12-05	View
510(k)	K163480	Renamel NANO +plus	EBF	2017-02-24	View
510(k)	K092730	COSMEDENT BRUSHABLE COMPOSITE	EBF	2009-11-20	View
510(k)	K070583	NANO COMPOSITE	EBF	2007-04-16	View
510(k)	K060881	TEMPORARY CROWN & BRIDGE RESIN	EBG	2006-05-16	View
510(k)	K052263	MULTIPLE (TOOTH DESENSITIZER)	LBH	2005-12-16	View
510(k)	K052501	MULTIPLE RESIN TOOTH BONDING AGENT	KLE	2005-10-21	View
510(k)	K042823	COSMEDENT PIT & FISSURE SEALANT	EBC	2004-12-01	View
510(k)	K041229	MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)	ELW	2004-06-17	View
510(k)	K040994	COSMEDENT CORE PASTE	EBF	2004-06-03	View
510(k)	K030832	PRIMOSPLINT SYSTEM	MQC	2003-09-17	View
510(k)	K011239	GINDA GUARD	EBD	2002-02-14	View
510(k)	K993659	RENAMEL PACK	EBF	2000-01-18	View
510(k)	K993658	RENAMEL SCULPT	EBF	2000-01-18	View
510(k)	K980800	LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL	EBF	1998-11-09	View
510(k)	K980799	HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL	EBG	1998-10-28	View
510(k)	K980298	FLOWABLE HYBRID	EBD	1998-03-09	View