Ultradent Products Inc. / OraTech LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3004977131	3004977131	Ultradent Products Inc. / OraTech LLC	1	N	2020-04-25	10075 South Jordan Gateway South Jordan UT US 84095

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
147747	1688310047	K993846	ULTRASEAL XT PLUS	EBC	2000-02-16
147747	1151016591	K981596	ULTRAPAK E	MVL	1998-07-31
147747	1905435834	K970114	ULTRACAL XS	EJK	1997-03-14
147747	1356776641	K964808	SPETEMP	EMA	1997-02-26
147747	1265272595	K953526	SEEK	LFC	1995-09-05
147747	1974509465	K940860	CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS	ELW	1994-05-27
147747	1909329030	K931868	PRIMADRY PRODUCT LINE	EBC	1993-07-22
147747	1871468974	K931867	ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE	EBF	1993-09-09
147747	1527028567	K921601	ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE	JES	1992-06-16
147747	1935686762	K132109	ENAMELAST	LBH	2013-11-01
147747	1343251759	K123731	BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY	LFD	2013-01-04
147747	1717833249	K123215	VISCOSTAT CLEAR	MVL	2013-02-05
147747	1858258201	K103745	BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF	LFD	2011-07-20
147747	1384862609	K094006	OPAL BOND MV	DYH	2010-03-23
147747	1719148790	K083647	VALO, MODEL 5919	EBZ	2009-01-23
147747	1074148499	K061331	ORAL BALANCE LIQUID/ GEL	LFD	2006-07-25
147747	1015322198	K060335	FILE-EZE	KJJ	2006-02-24
147747	1040690046
147747	1640909979
147747	1702345850
147747	1795979637

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LFD	3	2013-01-04
MVL	2	2013-02-05
EBC	2	2000-02-16
LBH	1	2013-11-01
DYH	1	2010-03-23
EBZ	1	2009-01-23
KJJ	1	2006-02-24
EJK	1	1997-03-14
EMA	1	1997-02-26
LFC	1	1995-09-05
ELW	1	1994-05-27
EBF	1	1993-09-09
JES	1	1992-06-16