FDA.reportPublic FDA data

Keystone Industries

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22806291000121639Keystone Industries1N2026-01-01616 Hollywood Ave CHERRY HILL NJ US 08002
25186902518690Keystone Industries - Delran1N2026-01-012702 Cindel Drive, Unit #2 Cindel Business Park Delran NJ US 08075
25233202523320Keystone Industries1Y2026-01-0152 West King St Myerstown PA US 17067
30100027223010002722Keystone Industries - Gibbstown1N2026-01-01480 S Democrat Rd Gibbstown NJ US 08027

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
H66807003771Seity - Etch Gel 37% 50 ml Syringe+1(800)333-3131tschwear@keystoneind.com
H66807021771M&S - Etch Gel 37% 50 ml Syringe+1(800)333-3131tschwear@keystoneind.com
H66807027771Seity - Etch Gel 37% 12 g Syringe+1(800)333-3131tschwear@keystoneind.com
H6682030051iSmile - iSmile Etch Gel 37% Bulk Syringe (50ml)+1(800)333-3131tschwear@keystoneind.com
H66842201141HeyGears - KeySplint Hard for HeyGears, 1 kg+1(800)333-3131tschwear@keystoneind.com
H66842201151KeySplint Soft for HeyGears - KeySplint Soft for HeyGears 1 kg+1(800)333-3131tschwear@keystoneind.com
H66850524011Nexa3D - KeySplint Soft for Nexa3D, 5 kg+1(800)333-3131tschwear@keystoneind.com
H66852233011Nexa3D - KeySplint Hard for Nexa3D, 5 kg+1(800)333-3131tschwear@keystoneind.com

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
141751255868142K991687MODIFICATION TO LINER II: SOFT RELINE LIQUIDEBI1999-10-07
141761255868142K991687MODIFICATION TO LINER II: SOFT RELINE LIQUIDEBI1999-10-07
1621191255868142K991687MODIFICATION TO LINER II: SOFT RELINE LIQUIDEBI1999-10-07
141751776442078K991631FASTRAY LCELW1999-07-26
141751998406900K983876MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLICEBI1998-12-16
141761998406900K983876MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLICEBI1998-12-16
1621191998406900K983876MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLICEBI1998-12-16
141751827693478K983752ALUMINA-ZINC OXIDE POWDERS F AND REMA1998-12-10
1621191827693478K983752ALUMINA-ZINC OXIDE POWDERS F AND REMA1998-12-10
141751441341102K981861LINER 1:HARD RELINE LIQUIDEBI1998-10-01
141761441341102K981861LINER 1:HARD RELINE LIQUIDEBI1998-10-01
1621191441341102K981861LINER 1:HARD RELINE LIQUIDEBI1998-10-01
141751014205739K981691SILICONE SOFT RELINEEBI1998-11-03
1621191014205739K981691SILICONE SOFT RELINEEBI1998-11-03
141751356581026K973201PROVI CEMENTEMA1998-06-05
1621191356581026K973201PROVI CEMENTEMA1998-06-05
141751008905363K963652PULPDENT DESENSITIZEREBF1996-10-11
141751208460468K961201BOSWORTH IMPRESSION MATERIAL IIELW1996-05-17
141751195683650K961199BOSWORTH TEMPORARY RESINEBG1996-06-25
1621191195683650K961199BOSWORTH TEMPORARY RESINEBG1996-06-25
141751916427701K940402SUPERGEL/SUPPRESSED DUSTELW1994-03-28
141751330906594K933505BOSWORTH COPALIONERLBH1994-01-07
1621191330906594K933505BOSWORTH COPALIONERLBH1994-01-07
141751108732844K930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMELW1994-01-07
141751786415976K926033VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORDELW1993-05-05
141751444098195K864757MODIFIED VINYLAC PRESS PACK DENTURE RESINEBI1987-02-10
141751443226438K832752COMFORT CUSHION DISPOS. ANALGESISCBN1983-12-08
141751558917766K801380CROWN DELTA SILICONE IMPRESSION MATERIALELW1980-07-08
141751492348363K250489FP3DEBI2025-05-20
141751928357055K241089KeyPrint KeyDenture BaseEBI2024-10-24
141761928357055K241089KeyPrint KeyDenture BaseEBI2024-10-24
1621191928357055K241089KeyPrint KeyDenture BaseEBI2024-10-24
141752013045648K203000KeyPrint KeySplint HardMQC2021-04-09
141762013045648K203000KeyPrint KeySplint HardMQC2021-04-09
1621192013045648K203000KeyPrint KeySplint HardMQC2021-04-09
141751923333430K183598KeyPrint KeySplint SoftMQC2019-11-15
141761923333430K183598KeyPrint KeySplint SoftMQC2019-11-15
1621191923333430K183598KeyPrint KeySplint SoftMQC2019-11-15
141751718139281K172764KeymillEBI2018-04-27
1621191718139281K172764KeymillEBI2018-04-27
141751400577701K152051ClearMetEBI2016-03-22
141751591587211K123787GREENCROSS SURGICAL MASKFXX2013-07-17
141751583149266K112597SEITY 37% PHOSPHORIC ACID ETCHANT GELKLE2011-12-07
1621191583149266K112597SEITY 37% PHOSPHORIC ACID ETCHANT GELKLE2011-12-07
141752019925393K110468FREEWAY COMFORT BITE GUARDMQC2011-08-05
141751362404433K100731BOSWORTH AIR POLISHEREFB2010-12-03
141751298941465K071886SELF SEAL STERILIZATION POUCHFRG2007-12-27
141751265472817K060377DR DISPOSABLE PROPHY ANGLE MODEL H310EGS2006-04-26
141751396747422K051224BOSWORTH SEALEBC2005-07-28
1621191396747422K051224BOSWORTH SEALEBC2005-07-28
141751483042688K042048GELATO PROPHYLAXIS PASTEEJR2004-10-26
1621191483042688K042048GELATO PROPHYLAXIS PASTEEJR2004-10-26
141751548455552K041028CROWN DELTA HYDROPHILIC IMPRESSION MATERIALELW2004-05-14
141751880937249K033751AEGIS PIT & FISSURE SEALANT WITH ACPEBC2004-02-05
1621191880937249K033751AEGIS PIT & FISSURE SEALANT WITH ACPEBC2004-02-05
141751136780907K032773DIAMOND D HIGH IMPACT DENTURE ACRYLICEBI2003-09-23
141761136780907K032773DIAMOND D HIGH IMPACT DENTURE ACRYLICEBI2003-09-23
1621191136780907K032773DIAMOND D HIGH IMPACT DENTURE ACRYLICEBI2003-09-23
141751534948464K031811PIT & FISSURE SEALANT WITH FLUORIDEEBC2003-09-04
1621191534948464K031811PIT & FISSURE SEALANT WITH FLUORIDEEBC2003-09-04
141751547958448K030859NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAINEIH2003-03-27
1621191547958448K030859NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAINEIH2003-03-27
141751210943126K023755WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELDFXX2003-06-10
141751358456211K012882BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060EBI2001-11-14
141761358456211K012882BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060EBI2001-11-14
1621191358456211K012882BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060EBI2001-11-14
141751101630061
141751114434084
141761114434084
1621191114434084
141751486044472
141751651118348
141751721916659
141751809700272
141761990107552
141751001195922
141751033282241
141761033282241
1621191033282241
1621191047733382
141751052061536
141751104629608
141751139093931
141751171293638
141751172124092
141751183673000
141751221637997
141751283428124
1621191283428124
141751295073011
141751295338759
141761295338759
1621191295338759
141751348652345
1621191348652345
2753051348652345
141751388976605
141751396724492
141751416798538
141751444366069
141751454167849
141751471074192
141751483484051
141751488716270
141761488716270
1621191488716270
141751500275494
141751564970795
141751574332248
141751590113532
141751597047937
141751635358409
141751647245475
141751672393148
141751688386319
141751705241238
141751732207885
141751807684752

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBI252025-05-20
MQC72021-04-09
ELW72004-05-14
EBC62005-07-28
EMA41998-12-10
EBG31996-06-25
FXX22013-07-17
KLE22011-12-07
EJR22004-10-26
EIH22003-03-27
EBF21999-12-21
LBH21994-01-07
EFB12010-12-03
FRG12007-12-27
EGS12006-04-26
CBN11983-12-08

PMN#

FP3D

2025-05-20

Keystone Industries

GUDID#

200 records. Showing 1-40. Next