FDA.reportPublic FDA data

Keystone Industries - Gibbstown

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30100027223010002722Keystone Industries - Gibbstown1N2026-01-01480 S Democrat Rd Gibbstown NJ US 08027

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1621191685992821K993716PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUEEBF1999-12-21
1621191255868142K991687MODIFICATION TO LINER II: SOFT RELINE LIQUIDEBI1999-10-07
1621191998406900K983876MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLICEBI1998-12-16
1621191827693478K983752ALUMINA-ZINC OXIDE POWDERS F AND REMA1998-12-10
1621191441341102K981861LINER 1:HARD RELINE LIQUIDEBI1998-10-01
1621191014205739K981691SILICONE SOFT RELINEEBI1998-11-03
1621191356581026K973201PROVI CEMENTEMA1998-06-05
1621191195683650K961199BOSWORTH TEMPORARY RESINEBG1996-06-25
1621191330906594K933505BOSWORTH COPALIONERLBH1994-01-07
1621191928357055K241089KeyPrint KeyDenture BaseEBI2024-10-24
1621192013045648K203000KeyPrint KeySplint HardMQC2021-04-09
1621191923333430K183598KeyPrint KeySplint SoftMQC2019-11-15
1621191718139281K172764KeymillEBI2018-04-27
1621191583149266K112597SEITY 37% PHOSPHORIC ACID ETCHANT GELKLE2011-12-07
1621191396747422K051224BOSWORTH SEALEBC2005-07-28
1621191483042688K042048GELATO PROPHYLAXIS PASTEEJR2004-10-26
1621191880937249K033751AEGIS PIT & FISSURE SEALANT WITH ACPEBC2004-02-05
1621191136780907K032773DIAMOND D HIGH IMPACT DENTURE ACRYLICEBI2003-09-23
1621191534948464K031811PIT & FISSURE SEALANT WITH FLUORIDEEBC2003-09-04
1621191547958448K030859NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAINEIH2003-03-27
1621191358456211K012882BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060EBI2001-11-14
1621191114434084
1621191033282241
1621191047733382
1621191283428124
1621191295338759
1621191348652345
1621191488716270
1621191843506140
1621191954801722
1621191990107552
1621191997658579
1621192063414723

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBI82024-10-24
EBC32005-07-28
MQC22021-04-09
EMA21998-12-10
KLE12011-12-07
EJR12004-10-26
EIH12003-03-27
EBF11999-12-21
EBG11996-06-25
LBH11994-01-07