Ultradent Products, Inc.

FDA 510(k) & PMA Approved Devices — 102 products

Total Devices102

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K262228	Transcend Bulk Fill Flowable Composite	EBF	2026-07-01	View
510(k)	K261404	UltraEZ	LBH	2026-04-30	View
510(k)	K240743	Peak Universal Bond	KLE	2024-03-20	View
510(k)	K240694	FORMA Composite (Shade A3D)	EBF	2024-03-15	View
510(k)	K221909	J-Temp	EBF	2022-07-01	View
510(k)	K220471	VALO X, VALO X Accessory Lenses	EBZ	2022-02-22	View
510(k)	K211905	UltraCal XS	KIF	2021-10-13	View
510(k)	K211237	UltraTemp Rez II	EMA	2021-07-13	View
510(k)	K210550	VALO Grand Corded and Accessory Lenses	EBZ	2021-03-01	View
510(k)	K190627	VALO Grand Corded	EBZ	2019-04-29	View
510(k)	K173163	ChlorCid, ChlorCid V, ChlorCid Surf	KJJ	2018-02-09	View
510(k)	K160551	VALO Grand	EBZ	2016-07-13	View
510(k)	K131357	PEAK Z	KLE	2013-09-06	View
510(k)	K123215	VISCOSTAT CLEAR	MVL	2013-02-05	View
510(k)	K112517	ULTRASEAL XT HYDRO	EBC	2011-09-23	View
510(k)	K111836	PERMASHADE VENEER CEMENT	EMA	2011-09-16	View
510(k)	K111696	OPAL BAND CEMENT	DYH	2011-09-07	View
510(k)	K111017	CLEARTEMP	EMA	2011-06-06	View
510(k)	K110582	VALO CORDLESS	EBZ	2011-04-28	View
510(k)	K101245	ULTRASEAL ID	EBC	2010-09-17	View