JMU DENTAL, INC

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3014683120	3014683120	JMU DENTAL, INC	1	N	2026-01-01	150 E Lambert Rd Fullerton CA US 92835

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
220744	1072655425	K990668	POWDER FREE BLUE NITRILE GLOVE	LZA	1999-06-03
220744	1665372876	K982872	TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)	LYY	1998-10-15
220744	1430012438	K970794	LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)	LYY	1997-05-06
220744	1960548691	K923757	DENTAL DIAMOND DRILLS	DZP	1993-03-16
220744	1244451875	K242740	Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)	EIH	2024-12-05
220744	1225049234	K241565	Sterilization Package/Reel	FRG	2025-02-24
220744	1055053592	K233918	Dental Barrier and Sleeves	PEM	2024-05-09
220744	1594696101	K222103	Nitrile Patient Examination Gloves, Powder Free, Pink Color	LZA	2023-08-24
220744	1870906778	K222096	Endo Ultrasonic Activator	ELC	2023-03-23
220744	1039027701	K221165	Non-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 Fentanyl	LZA	2022-11-20
220744	1031391918	K220831	Dental Implantation Systems, Dental Electrical Motors	EBW	2022-09-27
220744	2008646248	K220829	Endo Motor	EKX	2023-05-18
220744	1339515341	K220826	LED Curing Light	EBZ	2022-12-08
220744	1923630068	K220597	Disposable Surgical Face Mask (FM-34EE,FM-44EE)	FXX	2022-05-26
220744	1808562506	K220179	High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors	EFB	2023-09-22
220744	1983432625	K212279	Digital Intraoral X-ray Imaging System	MUH	2021-10-07
220744	1253766615	K212178	Root Apex Locator	LQY	2022-07-20
220744	1539433828	K212080	Imaging Plate Scanner, i-Scan	MUH	2021-09-27
220744	1030907941	K210231	Vittra APS Unique	EBF	2021-10-14
220744	1968470586	K203706	Dental Electric Motor	EBW	2022-01-13
220744	1236186019	K203320	Endo Motor	EKX	2021-05-10
220744	1439526821	K201684	A-Silicone for Bite Registration	ELW	2020-09-24
220744	1295033671	K201530	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey)	LZA	2020-08-05
220744	1952435612	K193581	Non-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 - Oyster	LZA	2020-03-20
220744	1266259655	K193561	Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch	FRG	2020-04-15
220744	1491888452	K192682	Orthocem, Ortho Bite	DYH	2020-08-14
220744	1504783914	K183465	Allcem, Allcem Core	EMA	2019-11-02
220744	1744409412	K183424	Ambar, Ambar APS, Ambar Universal APS	KLE	2019-12-13
220744	1866570731	K182308	Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs	LZA	2019-05-30
220744	1408152647	K181957	Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted	FRG	2019-07-09
220744	1663837835	K181087	Apex Locator, DPEX III	LQY	2018-12-18
220744	1912655072	K171823	U&U Indicator tape and strip	JOJ	2018-02-22
220744	1595382179	K170229	Dental High-speed Turbine Handpiece	EFB	2017-11-08
220744	1213857289	K162258	Self Sealing Sterilization Pouches	FRG	2017-04-28
220744	1556771353	K152766	CharmFlex	ELW	2016-03-08
220744	1655372475	K142685	NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE	LZA	2015-02-11
220744	1257891542	K133071	ELASTIC IMPRESSION MATERIAL	ELW	2014-05-28
220744	1836415035	K123869	POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES	LZA	2013-02-28
220744	1881237007	K121526	POWER-FREE NITRILE PATIENT EXAMINATION GLOVES	LZA	2012-08-03
220744	1547831829	K111290	PIEZO BONE SURGERY	DZI	2011-11-18
220744	1920508286	K101567	SHARPS CONTAINER	MMK	2010-09-02
220744	1090830628	K101029	KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH	ELM	2010-08-16
220744	1119628141	K080025	LED.L, LED.M, LED.G, LED.B	EBZ	2008-03-19
220744	1425888613	K071886	SELF SEAL STERILIZATION POUCH	FRG	2007-12-27
220744	1336245511	K053555	ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L	ELC	2006-08-21
220744	1008507003
220744	1010749840
220744	1011414280
220744	1027353912
220744	1028705485
220744	1058153862
220744	1077248063
220744	1077664113
220744	1095073232
220744	1107819981
220744	1107917135
220744	1110000420
220744	1115174382
220744	1121957422
220744	1152031221
220744	1154625018
220744	1162015426
220744	1172392784
220744	1175463439
220744	1180573919
220744	1206384575
220744	1213335224
220744	1220318737
220744	1227159570
220744	1238633862
220744	1248562012
220744	1285492057
220744	1292868659
220744	1300365081
220744	1302816144
220744	1319302043
220744	1332691830
220744	1340810669
220744	1349384650
220744	1357387471
220744	1357866993
220744	1360409164
220744	1385636489
220744	1395381278
220744	1396439599
220744	1397341316
220744	1403056286
220744	1437468796
220744	1447912452
220744	1486264993
220744	1500151114
220744	1504486533
220744	1506255081
220744	1517274116
220744	1520055835
220744	1526447504
220744	1536076274
220744	1536981376
220744	1541281930
220744	1542531702
220744	1545844880
220744	1559358663
220744	1598672136
220744	1600920857
220744	1603884097
220744	1612222000
220744	1622937155
220744	1628282121
220744	1628515008
220744	1635429470
220744	1637115365
220744	1650674919
220744	1669000996
220744	1681991400
220744	1687930029
220744	1713867686
220744	1714803270
220744	1719297627
220744	1722172074
220744	1724923708

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
LZA	9	2023-08-24
FRG	5	2025-02-24
ELW	3	2020-09-24
EFB	2	2023-09-22
EKX	2	2023-05-18
ELC	2	2023-03-23
EBZ	2	2022-12-08
EBW	2	2022-09-27
LQY	2	2022-07-20
MUH	2	2021-10-07
LYY	2	1998-10-15
EIH	1	2024-12-05
PEM	1	2024-05-09
FXX	1	2022-05-26
EBF	1	2021-10-14
DYH	1	2020-08-14
KLE	1	2019-12-13
EMA	1	2019-11-02
JOJ	1	2018-02-22
DZI	1	2011-11-18
MMK	1	2010-09-02
ELM	1	2010-08-16
DZP	1	1993-03-16