Parkell, Inc.

FDA 510(k) & PMA Approved Devices — 50 products

Total Devices50

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K243254	Parkell Pit and Fissure Sealant	EBC	2025-08-08	View
510(k)	K210259	Parkell Self-Adhesive Cement	EMA	2022-01-20	View
510(k)	K191103	Parkell Desensitizer Gel	EJK	2019-11-22	View
510(k)	K190930	SmarTemp X1	EBG	2019-09-05	View
510(k)	K182296	HyperFil-LV	EBF	2018-12-14	View
510(k)	K172176	Parkell Universal Adhesive	KLE	2017-11-21	View
510(k)	K113839	RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE	MVL	2012-04-12	View
510(k)	K101044	RETRIEVE IMPLANT CEMENT	EMA	2010-06-10	View
510(k)	K080549	DURAFINISH ALL-CURE, MODEL S296	EBD	2008-05-13	View
510(k)	K073698	SECURE	EMA	2008-03-19	View
510(k)	K062518	CELERITY	EBF	2006-12-04	View
510(k)	K063003	AURORA	EBZ	2006-11-28	View
510(k)	K060946	CZ-S2000	KIF	2006-06-15	View
510(k)	K053516	MUCOHARD	EBI	2006-01-26	View
510(k)	K040599	PARKELL RESIN GLAZE	EBD	2004-04-09	View
510(k)	K032179	COMP. E	KLE	2003-09-09	View
510(k)	K031212	TEMPORARY RESIN CEMENT	EMA	2003-07-11	View
510(k)	K022097	THERMIQUE	EAT	2002-09-06	View
510(k)	K020239	TOUCH&BOND-PLUS	KLE	2002-03-20	View
510(k)	K012360	LC TEMPORARY FILLING	EBG	2001-09-06	View