PREMIER DENTAL PRODUCTS CO.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2511556	2511556	PREMIER DENTAL PRODUCTS CO.	1	Y	2026-01-01	1710 Romano Dr PLYMOUTH MEETING PA US 19462

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
7593	1514387613	K972138	CARR RIGID CONTAINER SYSTEM	FRG	1997-11-13
7593	1300463042	K970992	PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS	GEH	1997-06-17
7593	1703114397	K945492	HIGH TEMPERATURE CAUTERY	GEI	1995-01-30
7593	1446317133	K933766	HIGH-Q-BOND	EBF	1994-01-26
7593	1097171290	K932827	ALPHA-DENT CORE BUILDUP PASTE	EBF	1993-09-23
7593	1229405150	K924823	MICRODOSE SILANE	ELL	1993-03-16
7593	1387112178	K923332	ELECTROSURGICAL ELECTRODES	GEI	1992-10-13
7593	1635195127	K896303	BIOPSY PUNCH	LRY	1990-02-13
7593	1644400585	K884015	PREMIER DECANNULATION STOPPER	BTO	1988-11-03
7593	1872417994	K260682	Bond-PR™ Universal Adhesive	KLE	2026-03-03
7593	1543755900	K253513	MultiMatch Flow Chameleon AntiMicrobial Composite	EBF	2025-11-07
7593	2070837987	K223632	Premier's MultiMatch Universal Chameleon Restorative Composite	EBF	2022-12-06
7593	2060168810	K180682	AeroPro Cordless Prophy System	EKX	2019-02-27
7593	1749956977	K161580	Premier Sealant	EBC	2016-10-18
7593	1824030087	K153334	Oral-B 5% Sodium Fluoride Varnish	LBH	2016-05-20
7593	2034927613	K151123	Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film	PEM	2016-03-03
7593	2019421233	K150601	Zeramic Adhesive Resin Cement	EMA	2015-07-22
7593	1509703727	K141839	PREMIER ETCH	KLE	2014-11-17
7593	1083551376	K132526	KNIT-PAK+	MVL	2013-11-26
7593	1699659673	K131212	PREMIER CERAMIC PRIMER	KLE	2013-08-26
7593	1666156176	K102006	CRYOMEGA	GEH	2010-10-06
7593	1720302758	K083695	TRAXODENT	MVL	2009-04-28
7593	1934676765	K062683	ENAMEL PRO VARNISH	LBH	2006-11-21
7593	1744626959	K062166	ENAMEL PRO	EJR	2006-11-21
7593	2070450598	K061998	PREMIER SELF-ETCHING BOND ENHANCER	KLE	2006-10-04
7593	1709349471	K051866	PREMIER TEMPORARY CEMENT	EMA	2005-09-06
7593	1670365480	K040098	VARNISHAMERICA	LBH	2004-02-04
7593	1370507764	K033309	PREMIER IMPLANT CEMENT, MODEL 3001450	EMA	2004-01-26
7593	1682715975	K031463	MARINA MEDICAL SILICONE PESSARY	HHW	2003-11-18
7593	1870301256	K012160	COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408	EBF	2001-09-27
7593	1841044449	K010195	PREMIER ULTRASONIC SCALER AND INSERTS	ELC	2001-04-17
7593	1083548239	K002042	TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018	HGI	2001-02-01
7593	1155477676
7593	1259901368
7593	1260994469
7593	1318921301
7593	1665343614
7593	1889551327
7593	1011221493
7593	1029944973
7593	1044878993
7593	1058923024
7593	1091600799
7593	1096660348
7593	1102967814
7593	1109374664
7593	1109502699
7593	1132743499
7593	1134279633
7593	1176802471
7593	1179172608
7593	1199627495
7593	1201998550
7593	1218168993
7593	1258051775
7593	1258582127
7593	1266365291
7593	1271170737
7593	1278945846
7593	1281229068
7593	1290332459
7593	1292866517
7593	1293438411
7593	1320135808
7593	1321232558
7593	1333374678
7593	1336384091
7593	1338611984
7593	1346237435
7593	1380122736
7593	1383348917
7593	1392391414
7593	1434244831
7593	1438505199
7593	1448412447
7593	1485083347
7593	1503557287
7593	1505563183
7593	1508768526
7593	1522469057
7593	1547983930
7593	1558010900
7593	1580583955
7593	1597670080
7593	1607574945
7593	1610649947
7593	1616222631
7593	1617717692
7593	1620168757
7593	1644472538
7593	1647483626
7593	1668251452
7593	1671962303
7593	1673315289
7593	1699694956
7593	1719296185
7593	1733554538
7593	1750146443
7593	1760232191
7593	1773504970
7593	1778744733
7593	1786403144
7593	1797110600
7593	1827739540
7593	1835836485
7593	1857272739
7593	1869895850
7593	1899323809
7593	1902817972
7593	1919504109
7593	1929245185
7593	1952143045
7593	1962709545
7593	1976791632
7593	2003097016
7593	2013091134
7593	2041652246
7593	2041868722
7593	2044448582

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
EBF	5	2025-11-07
KLE	4	2026-03-03
LBH	3	2016-05-20
EMA	3	2015-07-22
MVL	2	2013-11-26
GEH	2	2010-10-06
GEI	2	1995-01-30
EKX	1	2019-02-27
EBC	1	2016-10-18
PEM	1	2016-03-03
EJR	1	2006-11-21
HHW	1	2003-11-18
ELC	1	2001-04-17
HGI	1	2001-02-01
FRG	1	1997-11-13
ELL	1	1993-03-16
LRY	1	1990-02-13
BTO	1	1988-11-03

PMN#

PREMIER ETCH
2014-11-17
PREMIER DENTAL PRODUCTS CO.
KNIT-PAK+
2013-11-26
PREMIER DENTAL PRODUCTS CO.
PREMIER CERAMIC PRIMER
2013-08-26
PREMIER DENTAL PRODUCTS CO.
TRAXODENT
2009-04-28
PREMIER DENTAL PRODUCTS CO.
ENAMEL PRO VARNISH
2006-11-21
PREMIER DENTAL PRODUCTS CO.
ENAMEL PRO
2006-11-21
PREMIER DENTAL PRODUCTS CO.
PREMIER SELF-ETCHING BOND ENHANCER
2006-10-04
PREMIER DENTAL PRODUCTS CO.
PREMIER SELF-ETCHING ENAMEL SEALANT
2006-10-04
PREMIER DENTAL PRODUCTS CO.
PREMIER TEMPORARY CEMENT
2005-09-06
PREMIER DENTAL PRODUCTS CO.
RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT
2004-09-21
PREMIER DENTAL PRODUCTS CO.
PREMIER IMPLANT CEMENT, MODEL 3001450
2004-01-26
PREMIER DENTAL PRODUCTS CO.
COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
2001-09-27
PREMIER DENTAL PRODUCTS CO.
PREMIER ULTRASONIC SCALER AND INSERTS
2001-04-17
PREMIER DENTAL PRODUCTS CO.
PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS
1997-06-17
PREMIER DENTAL PRODUCTS CO.
PREMIER PROMAX BITE GUARD
1995-04-05
PREMIER DENTAL PRODUCTS CO.
PREMIER MIRROR WARMER
1995-01-18
PREMIER DENTAL PRODUCTS CO.
ELECTROSURGICAL ELECTRODES
1992-10-13
PREMIER DENTAL PRODUCTS CO.
HARDCOATED PLASTIC FILLING INSTRUMENT
1991-06-24
PREMIER DENTAL PRODUCTS CO.
ENAMEL MICROABRASION COMPOUND
1989-06-09
PREMIER DENTAL PRODUCTS CO.
INTRAUTERINE DEVICE REMOVER
1984-10-12
PREMIER DENTAL PRODUCTS CO.
ELEVATOR - VARIOUS
1984-06-15
PREMIER DENTAL PRODUCTS CO.
BIOPSY PUNCH, VARIOUS
1984-06-08
PREMIER DENTAL PRODUCTS CO.
TONSIL KNIFE-VARIOUS
1984-05-30
PREMIER DENTAL PRODUCTS CO.
EAR KNIFE-VARIOUS
1984-05-30
PREMIER DENTAL PRODUCTS CO.
EAR CURETTE, VARIOUS
1984-05-29
PREMIER DENTAL PRODUCTS CO.
SURGICAL CURETTE, VARIOUS
1984-05-11
PREMIER DENTAL PRODUCTS CO.
OPHTHALMIC CURETTE-VARIOUS
1984-05-09
PREMIER DENTAL PRODUCTS CO.
LACHRYMAL PROBES-VARIOUS
1984-05-09
PREMIER DENTAL PRODUCTS CO.
SURGICAL RETRACTORS-VARIOUS
1984-05-01
PREMIER DENTAL PRODUCTS CO.
SURGICAL HOOKS, VARIOUS
1984-05-01
PREMIER DENTAL PRODUCTS CO.
PROBES, VARIOUS
1984-03-20
PREMIER DENTAL PRODUCTS CO.
PREMIER TRIPLE TRAY
1980-04-29
PREMIER DENTAL PRODUCTS CO.
PREMIER ABSORBENT POINTS
1980-04-29
PREMIER DENTAL PRODUCTS CO.
REPRODENT
1979-03-02
PREMIER DENTAL PRODUCTS CO.
ZYLOX
1979-02-21
PREMIER DENTAL PRODUCTS CO.
PREMIER INLAY PLACER
1978-06-30
PREMIER DENTAL PRODUCTS CO.
PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX
1978-06-30
PREMIER DENTAL PRODUCTS CO.
ZYTRON
1978-06-22
PREMIER DENTAL PRODUCTS CO.
PREMIER CARVERS, STYLE #21C & 21D
1978-04-19
PREMIER DENTAL PRODUCTS CO.