FDA.reportPublic FDA data

PAC-DENT INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20860433000719964PAC-DENT INC.1Y2026-01-01670 Endeavor Cir Brea CA US 92821

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2234711202747978K994224PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIALEBF2000-01-31
2234711524985559K994012TEMPOFIT, MODEL 02693EBG2000-02-16
2234712032622745K872745VINYL POLYSILOXANE IMPRESSION SYSTEMELW1987-07-21
2234711363156951K251775RODIN CementEMA2025-09-02
2234711606164600K240688RODIN Titan 3D ResinEBI2024-06-20
2234711259907249K231793RODIN 3D Resin SPLINT, Hard/FlexMQC2024-03-26
2234711069607534K231060ProMin Dental Desensitizing GelLBH2024-06-13
2234711414292272K223365RODIN Palette Naturalizing KitEBD2023-03-27
2234711869559272K210412Pac-Dent Ceramic Nanohybrid ResinEBF2021-07-26
2234711191434540K210189Pac-Dent Denture Base ResinEBI2021-07-28
2234711141706410K210186PacBond OneKLE2021-07-16
2234711614803443K202920OptiCompEBF2022-05-25
2234711464910019K202674Medidenta High Speed HandpiecesEFB2022-12-12
2234712054512661K200462EtchPro Etching GelKLE2020-09-02
2234711762814778K160577PacEndo ChlorhexidineKJJ2016-07-25
2234711036798069K160232Disposable Barrier Sleeves and CoversPEM2016-06-07
2234711154927236K153528PacEndo EDTAKJJ2016-02-01
2234711990782424K151852PacEndo Sodium HyprochloriteKJJ2015-11-10
2234711587134233K151150ElementsELW2015-07-28
2234711051279468K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPEM2016-03-03
2234711537289787K143411TRAUS ENDOEKX2015-06-29
2234711715257103K130672OPTIFLOW II FLOWABLE COMPOSITE, LCEBF2013-08-13
2234711912762923K113761INFRARED THERMOMETERFLL2012-09-07
2234711165051847K051952EUGENONEEMA2005-09-07
2234711204274082K030603PROANGLE DISPOSABLE PROPHY ANGLEEGS2003-04-14
2234711454788834K022675PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIALEBF2002-11-07
2234711868559703K012761PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANTEBC2001-11-01
2234711670333441K001108PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIALEBF2000-05-30
2234711147832135
2234711740900385
2234711757810561
2234711801689242
2234711842029807
2234712051987318
2234711040579597
2234711041575694
2234711042944912
2234711053216412
2234711088136569
2234711148412320
2234711168024738
2234711221937684
2234711236985685
2234711268458368
2234711289332923
2234711290470365
2234711302537936
2234711346185919
2234711350737861
2234711373587652
2234711383919389
2234711393699215
2234711423849841
2234711448289690
2234711486665427
2234711503864838
2234711508867149
2234711514534816
2234711516127737
2234711541307982
2234711557525517
2234711574223249
2234711574657392
2234711600128303
2234711638984421
2234711668814603
2234711678974642
2234711681596268
2234711697866373
2234711712345139
2234711723128343
2234711743201649
2234711745357669
2234711762645738
2234711764369625
2234711768821377
2234711785843111
2234711804041398
2234711821118804
2234711822168963
2234711823606049
2234711836812926
2234711838882104
2234711847002329
2234711873858573
2234711896616446
2234711912297525
2234711949502770
2234711949936962
2234711957226661
2234711964409919
2234711969375323
2234711982059442
2234711996478667
2234712005634730
2234712015309250
2234712033867943
2234712036660340
2234712065793449

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF62022-05-25
KJJ32016-07-25
EMA22025-09-02
EBI22024-06-20
KLE22021-07-16
PEM22016-06-07
ELW22015-07-28
LBH12024-06-13
MQC12024-03-26
EBD12023-03-27
EFB12022-12-12
EKX12015-06-29
FLL12012-09-07
EGS12003-04-14
EBC12001-11-01
EBG12000-02-16

PMN#

Elements

2015-07-28

PAC-DENT INTERNATIONAL, INC.

GUDID#

200 records. Showing 1-40. Next