FDA.reportPublic FDA data

JMU DENTAL, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30146831203014683120JMU DENTAL, INC1N2026-01-01150 E Lambert Rd Fullerton CA US 92835

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2207441072655425K990668POWDER FREE BLUE NITRILE GLOVELZA1999-06-03
2207441665372876K982872TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)LYY1998-10-15
2207441430012438K970794LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)LYY1997-05-06
2207441960548691K923757DENTAL DIAMOND DRILLSDZP1993-03-16
2207441167133925K250606Dental Barrier and SleevesPEM2025-05-29
2207441244451875K242740Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)EIH2024-12-05
2207441225049234K241565Sterilization Package/ReelFRG2025-02-24
2207441043821292K241036Autoclave Indicator Tape; EO Indicator TapeJOJ2024-12-17
2207441055053592K233918Dental Barrier and SleevesPEM2024-05-09
2207441594696101K222103Nitrile Patient Examination Gloves, Powder Free, Pink ColorLZA2023-08-24
2207441870906778K222096Endo Ultrasonic ActivatorELC2023-03-23
2207441039027701K221165Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and FentanylLZA2022-11-20
2207441031391918K220831Dental Implantation Systems, Dental Electrical MotorsEBW2022-09-27
2207442008646248K220829Endo MotorEKX2023-05-18
2207441339515341K220826LED Curing LightEBZ2022-12-08
2207441923630068K220597Disposable Surgical Face Mask (FM-34EE,FM-44EE)FXX2022-05-26
2207441808562506K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsEFB2023-09-22
2207441983432625K212279Digital Intraoral X-ray Imaging SystemMUH2021-10-07
2207441253766615K212178Root Apex LocatorLQY2022-07-20
2207441539433828K212080Imaging Plate Scanner, i-ScanMUH2021-09-27
2207441030907941K210231Vittra APS UniqueEBF2021-10-14
2207441968470586K203706Dental Electric MotorEBW2022-01-13
2207441236186019K203320Endo MotorEKX2021-05-10
2207441439526821K201684A-Silicone for Bite RegistrationELW2020-09-24
2207441295033671K201530Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)LZA2020-08-05
2207441952435612K193581Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - OysterLZA2020-03-20
2207441266259655K193561Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel PouchFRG2020-04-15
2207441491888452K192682Orthocem, Ortho BiteDYH2020-08-14
2207441504783914K183465Allcem, Allcem CoreEMA2019-11-02
2207441744409412K183424Ambar, Ambar APS, Ambar Universal APSKLE2019-12-13
2207441866570731K182308Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy DrugsLZA2019-05-30
2207441408152647K181957Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll GussetedFRG2019-07-09
2207441663837835K181087Apex Locator, DPEX IIILQY2018-12-18
2207441912655072K171823U&U Indicator tape and stripJOJ2018-02-22
2207441595382179K170229Dental High-speed Turbine HandpieceEFB2017-11-08
2207441213857289K162258Self Sealing Sterilization PouchesFRG2017-04-28
2207441556771353K152766CharmFlexELW2016-03-08
2207441655372475K142685NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREELZA2015-02-11
2207441257891542K133071ELASTIC IMPRESSION MATERIALELW2014-05-28
2207441836415035K123869POWDER-FREE NITRILE PATIENT EXAMINATION GLOVESLZA2013-02-28
2207441881237007K121526POWER-FREE NITRILE PATIENT EXAMINATION GLOVESLZA2012-08-03
2207441547831829K111290PIEZO BONE SURGERYDZI2011-11-18
2207441920508286K101567SHARPS CONTAINERMMK2010-09-02
2207441090830628K101029KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETHELM2010-08-16
2207441119628141K080025LED.L, LED.M, LED.G, LED.BEBZ2008-03-19
2207441425888613K071886SELF SEAL STERILIZATION POUCHFRG2007-12-27
2207441336245511K053555ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-LELC2006-08-21
2207441008507003
2207441009910613
2207441010749840
2207441011414280
2207441027353912
2207441028705485
2207441058153862
2207441077248063
2207441077664113
2207441095073232
2207441098707424
2207441107819981
2207441107917135
2207441110000420
2207441115174382
2207441121957422
2207441152031221
2207441154625018
2207441162015426
2207441172392784
2207441175463439
2207441180573919
2207441206384575
2207441213335224
2207441220318737
2207441227159570
2207441238633862
2207441248562012
2207441280983214
2207441285492057
2207441292868659
2207441296189058
2207441300365081
2207441302816144
2207441319302043
2207441332691830
2207441340810669
2207441349384650
2207441357387471
2207441357866993
2207441360409164
2207441385636489
2207441395381278
2207441396439599
2207441397341316
2207441403056286
2207441424956721
2207441437468796
2207441438964975
2207441447912452
2207441486264993
2207441500151114
2207441504486533
2207441506255081
2207441507973354
2207441517274116
2207441520055835
2207441522388415
2207441526447504
2207441536076274
2207441536981376
2207441541281930
2207441542531702
2207441545844880
2207441548635634
2207441559358663
2207441598672136
2207441600920857
2207441603884097
2207441612222000
2207441620278326
2207441622937155
2207441628282121

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA92023-08-24
FRG52025-02-24
ELW32020-09-24
PEM22025-05-29
JOJ22024-12-17
EFB22023-09-22
EKX22023-05-18
ELC22023-03-23
EBZ22022-12-08
EBW22022-09-27
LQY22022-07-20
MUH22021-10-07
LYY21998-10-15
EIH12024-12-05
FXX12022-05-26
EBF12021-10-14
DYH12020-08-14
KLE12019-12-13
EMA12019-11-02
DZI12011-11-18
MMK12010-09-02
ELM12010-08-16
DZP11993-03-16

GUDID#

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