FDA.reportPublic FDA data

PREMIER

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24388523003289183Premier Heart, LLC1N2026-01-01110 Main St Suites 201-88 Port Washington NY US 11050
25115562511556PREMIER DENTAL PRODUCTS CO.1Y2026-01-011710 Romano Dr PLYMOUTH MEETING PA US 19462
25214532521453PREMIER MEDICAL1N2026-01-0110090 SANDMEYER LN. PHILADELPHIA PA US 19116
30064597263006459726PREMIERE 1 DENTAL LABORATORY, L.L.C.1Y2026-01-01302 Manatee Avenue East Suite 201 Bradenton FL US 34208
30108004863010800486Premier Biotech, LLC1N2026-01-01725 Kasota Ave SE Minneapolis MN US 55414
30142589513014258951Premier Brands of America Inc.1N2026-01-01351 Fairview Ave Hudson NY US 12534
30144125313014412531PREMIER NORTH AMERICA, INC1Y2026-01-011321 NW 65TH PL STE 3 Ft Lauderdale FL US 33309
30170134383017013438PREMIER MEDICAL USA CORPORATION1Y2026-01-0127 Schoolhouse Rd Somerset NJ US 08873
30170488412434554PREMIER BRANDS OF AMERICA INC.1N2026-01-017 Corporate Drive Orangeburg NY US 10962
30178382573017838257PREMIER GUARD GLOBAL LIMITED1Y2026-01-0110320 Lake Rd Ste 101 Houston TX US 77070
30187339423018733942PREMIER MEDICAL PLUS, LLC1Y2026-01-0124123 Greenfield Road Suite 108 Southfield MI US 48075
30305950203030595020Premier Sperm Donors LLC1N2026-01-011611 Cloverleaf Dr Austin TX US 78723
30436250573043625057PREMIER ONLINE EXODONTIA COURSES, INC.1N2026-01-0126 Banerjee Bay Weyburn Saskatchewan CA S4H 3C3
24345542434554Premier Brands of America Inc.1N2020-04-25120 Pearl Street MOUNT VERNON NY US 10550
30054747153005474715PREMIER IMAGING/MEDICAL SYSTEMS, INC.1Y2020-04-25100 NORTH AVE NE Rome GA US 30161
30081401823008140182Premier Guard LLC1Y2020-04-252 Greenway Plz Ste 460 Houston TX US 77046
30099644023009964402PREMIER ORTHOPEDIC SUPPLY1Y2020-04-251014 Grand Blvd Ste 4 Deer Park NY US 11729
30165489653016548965PREMIER DENTAL LAB LLC1Y2020-04-25310 N County line Rd Hinsdale IL US 60521

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
749761141574254K992703CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800DQK2000-03-21
75931514387613K972138CARR RIGID CONTAINER SYSTEMFRG1997-11-13
75931300463042K970992PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUSGEH1997-06-17
75931703114397K945492HIGH TEMPERATURE CAUTERYGEI1995-01-30
75931446317133K933766HIGH-Q-BONDEBF1994-01-26
75931097171290K932827ALPHA-DENT CORE BUILDUP PASTEEBF1993-09-23
75931229405150K924823MICRODOSE SILANEELL1993-03-16
75931387112178K923332ELECTROSURGICAL ELECTRODESGEI1992-10-13
75931635195127K896303BIOPSY PUNCHLRY1990-02-13
75931644400585K884015PREMIER DECANNULATION STOPPERBTO1988-11-03
687961876733297K780722ADVANCED DENTURE SYSTEMEKO1978-05-26
75931872417994K260682Bond-PR™ Universal AdhesiveKLE2026-03-03
75931543755900K253513MultiMatch Flow Chameleon AntiMicrobial CompositeEBF2025-11-07
3458791757835803K231203Mosie Baby KitQYZ2023-11-29
75932070837987K223632Premier's MultiMatch Universal Chameleon Restorative CompositeEBF2022-12-06
2192371692531696K181659Avologi ENEOOHS2018-07-26
2170271302701989K181305OralTox Oral fluid Drug TestDJC2018-09-20
75932060168810K180682AeroPro Cordless Prophy SystemEKX2019-02-27
2170271471215861K171403OralTox Oral Fluid Drug TestDJC2018-02-02
75931749956977K161580Premier SealantEBC2016-10-18
75931824030087K153334Oral-B 5% Sodium Fluoride VarnishLBH2016-05-20
75932034927613K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPEM2016-03-03
75932019421233K150601Zeramic Adhesive Resin CementEMA2015-07-22
75931509703727K141839PREMIER ETCHKLE2014-11-17
75931083551376K132526KNIT-PAK+MVL2013-11-26
75931699659673K131212PREMIER CERAMIC PRIMERKLE2013-08-26
2170271906574875K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupDKZ2013-06-17
75931666156176K102006CRYOMEGAGEH2010-10-06
377601243406786K090848PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWMFQH2009-06-17
2375191243406786K090848PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWMFQH2009-06-17
75931720302758K083695TRAXODENTMVL2009-04-28
75931934676765K062683ENAMEL PRO VARNISHLBH2006-11-21
75921744626959K062166ENAMEL PROEJR2006-11-21
75931744626959K062166ENAMEL PROEJR2006-11-21
75932070450598K061998PREMIER SELF-ETCHING BOND ENHANCERKLE2006-10-04
687962034677761K061264TEMPFX ESTHETIC PROVISIONAL SYSTEMEBG2006-05-23
687962065284172K060507VALPLAST YAMAHACHI TEETHELM2006-04-07
75931709349471K051866PREMIER TEMPORARY CEMENTEMA2005-09-06
75931670365480K040098VARNISHAMERICALBH2004-02-04
75931370507764K033309PREMIER IMPLANT CEMENT, MODEL 3001450EMA2004-01-26
75931682715975K031463MARINA MEDICAL SILICONE PESSARYHHW2003-11-18
75931870301256K012160COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408EBF2001-09-27
75931841044449K010195PREMIER ULTRASONIC SCALER AND INSERTSELC2001-04-17
75931083548239K002042TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018HGI2001-02-01
377601089650327
1495891118368332
75921155477676
75931155477676
75921259901368
75931259901368
75931260994469
75931318921301
377601407681651
377601550668773
377601563308536
377601635157594
75921665343614
75931665343614
1495891827531650
377601860992927
75921889551327
75931889551327
75921919504109
75921961216004
2875651002847241
75931011221493
3484961025519324
75931029944973
75921044878993
75931044878993
2875651045606558
2170271053512438
75921058923024
75931058923024
2688891089650327
75931091600799
2170271093647835
2875651093762651
75931096660348
75921102967814
75931102967814
2170271103487560
75921109374664
75931109374664
75931109502699
75921132743499
75931132743499
75921134279633
75931134279633
75921152238396
75921165960771
3484961168355207
2170271170302941
75931176802471
75931179172608
2170271179386407
3484961190272844
75921199627495
75931199627495
75931201998550
2170271207323018
75921218168993
75931218168993
2170271256930262
75921258051775
75931258051775
75921258582127
75931258582127
75931266365291
2875651267633819
75921271170737
75931271170737
75931278945846
75931281229068
2170271282147529
2170271290278785
75921290332459

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF52025-11-07
KLE42026-03-03
LBH32016-05-20
EMA32015-07-22
DJC22018-09-20
MVL22013-11-26
GEH22010-10-06
FQH22009-06-17
EJR22006-11-21
DQK22000-03-21
GEI21995-01-30
QYZ12023-11-29
EKX12019-02-27
OHS12018-07-26
EBC12016-10-18
PEM12016-03-03
DKZ12013-06-17
EBG12006-05-23
ELM12006-04-07
HHW12003-11-18
ELC12001-04-17
HGI12001-02-01
FRG11997-11-13
ELL11993-03-16
LRY11990-02-13
BTO11988-11-03
EKO11978-05-26

NDC#

Enamelon

Premier Dental Products Company

stannous fluoride

Tolnaftate

Premier Brands of America Inc.

Antifungal Liquid Spray

Hydrocortisone

Premier Brands of America, Inc.

Hydrocortisone Continuous Spray

Salicylic Acid

Premier Brands of America Inc.

Clear Medicated Corn removers

Liquid Bandage

Premier Brands of America Inc.

Benzethonium chloride Plus Dyclonine hydrochloride

Miconazole nitrate

Premier Brands of America Inc.

Antifungal Miconazole Liquid Continuous Spray

Oxygen

Premier Medical Distribution

Oxygen

Oxygen

Premier Oxygen LLC

Oxygen

51 records. Showing 1-40. Next

PMA#

PMN#

Luminice

2022-02-24

Premier North America Inc.

KNIT-PAK+

2013-11-26

PREMIER DENTAL PRODUCTS CO.

TRAXODENT

2009-04-28

PREMIER DENTAL PRODUCTS CO.

AURORA SL

1999-11-18

PREMIER LASER SYSTEMS, INC.

AURORA HL

1999-09-22

PREMIER LASER SYSTEMS, INC.

BLULAZE

1999-08-20

PREMIER LASER SYSTEMS, INC.

AURORA

1998-11-23

PREMIER LASER SYSTEMS, INC.

CENTAURI

1998-10-09

PREMIER LASER SYSTEMS, INC.

81 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next