Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014683120

FEI Number

3014683120

Entity Name

JMU DENTAL, INC

City/State/Country

Fullerton, CA, US

Establishment Address

150 E Lambert Rd, Fullerton, CA 92835, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

JMU DENTAL, INC (Owner Number: 10058141)

Owner / Operator Contact Address

150 E Lambert Rd, Fullerton, CA 92835, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SMS Jacket, SMS Lab Coat, Isolation Gowns Dental Electric Motor / Dental Implantation System JMU Dental Impression Materials Hygienic Finger Cots BOUFFANT CAP DENTAL IMPRESSION TRAY, BITE REGISTRATION TRAY, DISPOSABLE IMPRESSION TRAY Jmu Wrap, Sterilization Pouch Biohazard Waste Bag; Degradable Garbage Bags Dental Retractor Pre Bent Needle Tips, Mixing Tips, Irrigation Syringe, Dental Needle JMU Surgical Rongeur Forcep Paper Tape JMU Nitrile Examination Gloves Dental stool Dental Binocular Loupes Articulating Papers Disposable Medical Device Self-seal Sterilization Pouch Endo Motor Dental Aspirating Syringe MATERIAL, IMPRESSION TRAY, RESIN Scissors, Surgical Tissue, Dental JMU Dental High-speed Turbine Handpiece UDS-N2 D3 Ultrasonic Scaler UDS-N6 LED UDS-N6 D5 D7 Ultrasonic Periodontal Treatment Device UDS-P V2 D7 LED UDS-N1 PT MASTER 3 S6 S6 LED UDS-L UDS-E LED V3 D6 U6 LED V1 D600 U600 PT-N5 LED U600 LED U6 UDS-N3 UDS-J ,D600 LED; PT5 V6 LED UDS-A D1 PT 3 UDS-M V6 Ultrasonic Scaler,Multiple Models D6 LED UDS-E UDS-K ABSORBENT TIPPED APPLICATOR JMU Absorbent Paper Points JMU Sectional Matrix Bands DENTAL CHAIR X-Ray Sensors MICROSCOPE INSTRUMENT, DIAMOND, DENTAL JMU Elastic Rolled Tourniquet JMU General Surgical Scissors ULTRASONIC CLEANER Autoclave Sterilization Wrap Sheets Sterilization Pouch NON-WOVEN SWAB (SPONGE); ALL-GAUZE SPONGES; COTTON FILLED EXODONTIA SPONGES Stainless Steel Tongue Cleaner HANDLE, INSTRUMENT, DENTAL JMU Dental X-Ray Positioning Aiming Ring Gutta Percha Obturator Premium Nitrile Examination Gloves, Pink Dental Blocks CAD/CAM Glass Ceramic Sterilizer Indicator Tape JMU Surgical Elevator COXO Handpiece, X TITAN Handpiece Cotton-Tipped Applicators MIRROR, MOUTH Mixing Tip JMU Dental Stool Gloves, Nitrile,3.5mil Mouthpiece, saliva Ejector ROOT APEX LOCATOR C-type cheek retractor DISPOSABLE DENTAL SYRINGE, AIR/WATER SYRINGE TIPS SHEETS FOR TRAYS ISOLATION GOWN, ISOLATION JACKET, ISOLATION LAB COAT NON-SURGICAL ISOLATION GOWN Level 1 / Level 3 Medical Masks CUTTER, WIRE Obturation System Impression Material POLYCOATED PAPER CUPS; PLASTIC CUPS DISPENSER, LIQUID MEDICATION Dental PRF Box & GRF Instruments Complete Set MICRO APPLICATOR; VALUSTICK STICKY APPLICATOR; BENDABLE BRUSH APPLICATOR; COMPOSITE BRUSH AND REPLACEABLE TIP JMU M3g Disposable Nitrile Examination Gloves JMU M3.5g Nitrile Examination Gloves, Black COTTON ROLL Phosphor Storage Plate Barrier Envelopes Sterilizer Indicator Tape LED Whitening Light, LED Curing Light Handpiece, direct drive, ac-powered CHAIR, EXAMINATION AND TREATMENT JMU Nitrile Examination Gloves MU Full Stainless Steel Four-Drawer Cabinet Gloves, Latex, 5mil EHM - STRIP, POLISHING AGENT Surgical Microscope JMU Sharps Container DENTAL BIB/ APRON Face Shield Safety Goggle Implant Irrigation Tubing Sterilization Pouch, Indicator baby tooth box; box; plastic dappen INTRA ORAL CAMERA Micro blaster Standard (Midwest) JMU Forward Pull Headgear Hot or cold disposable pack. Jmu 1st Molar Rough Band w/ Roth Tube 1st Molar Rough Band w/ MBT Tube DENTAL FLOSS JMU M3.5g Nitrile Examination Gloves, Size XS, Powder-Free, Non-Sterile, Rose Pink JMU Lingual Retainer Wires Dental Electric Motor SALIVA EJECTOR, EVACUATOR TIPS PLIER, ORTHODONTIC DISPOSABLE TRAPS (FILTER); PLASTIC RETAINER/ DENTURE; CUSPIDOR STRAINER; AMALGAM CARRIER Double-sided Plastic-coating Mixing Pad Spring Endo File JMU Power Chain Short JMU Mini Ligature O-Ties JMU Ligature O-Ties JMU Intra Oral Latex Free Elastics JMU Power Chain Continuous Orthodontic Elastics Placer JMU Intra Oral Latex Elastics JMU JMU Intra Oral Elastics Neon JMU Power Chain Long JMU Needle Holder 14 cm/5 ½ JMU Dental Anesthetic Needle TOOTHBRUSH Emesis Bag, Vomit Bag JMU Nitrile Examination Gloves Facebow Adhesive, Resin, Composite Endo Ultrasonic Activator Stainless Steel Surgical Blades and Handle Kit DYNAMIC HP MIXING TIPS; BENT NEEDLE TIPS; CURVED UTILITY SYRINGE; DISPENSING TIPS; IMPRESSION GUN; INTRA-ORAL TIPS JMU Nitrile Examination Gloves Face Shield RESIN Orthodontic Wax Articulator Jmu Gutta Percha Pluggers EVACUATOR, ORAL CAVITY Intraoral Camera A-Silicone Bite Registration Material JMU Dental LED Light JMU Sectional Matrix Bands Tongue Depressor Prophy Angles; Prophy Brushes; Prophy Cups; Disposable Prophy Angles; Disposable Prophy Cups

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FME	Gown, Examination	General Hospital	Class 1	880.6265	2025-06-25
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2023-05-15
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2023-05-15
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2023-05-15
ELW	Material, Impression	Dental	Class 2	872.3660	2024-07-18
LZB	Finger Cot	General Hospital	Class 1	880.6250	2024-05-13
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2019-04-30
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2019-04-30
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2018-11-06
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2019-08-07
FOB	Bedpan	General Hospital	Class 1	880.6730	2021-08-10
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2021-08-11
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2021-08-11
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2020-10-29
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-04-20
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-11-17
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2020-10-29
HJH	Loupe, Binocular, Low Power	Ophthalmic	Class 1	886.5120	2022-08-04
EFH	Paper, Articulation	Dental	Class 1	872.6140	2026-06-17
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2023-10-19
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2023-10-19
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2023-06-01
LQY	Locator, Root Apex	Unknown	Class U	N/A	2023-06-01
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2025-08-15
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2019-07-10
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2026-05-05
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2026-05-27
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2018-07-16
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2019-07-09
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2024-05-07
KCQ	Tube Impression And Matrix	Dental	Class 1	872.6570	2024-06-21
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2019-04-30
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2021-11-12
IBJ	Light, Microscope	Pathology	Class 1	864.3600	2024-08-15
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	2021-06-16
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2026-04-29
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-10-29
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2019-04-30
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-12-08
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-12-08
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-12-02
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-12-02
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2019-04-30
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2026-06-12
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2015-05-14
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2020-03-20
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2026-06-04
EKM	Gutta-Percha	Dental	Class 1	872.3850	2022-11-21
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-11-01
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2025-03-13
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2026-06-04
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2020-10-29
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2024-03-13
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2024-03-13
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2025-06-10
GCZ	Retainer, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-07-10
JEW	Tip, Rubber, Oral Hygiene	Dental	Class 1	872.6650	2022-01-27
FZM	Stool, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2024-08-01
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2020-02-13
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-07-10
LQY	Locator, Root Apex	Unknown	Class U	N/A	2023-05-15
EIG	Retractor, All Types	Dental	Class 1	872.4565	2026-06-19
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2019-04-30
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2021-08-17
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2019-04-30
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2024-05-30
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2020-03-20
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2022-08-04
ELW	Material, Impression	Dental	Class 2	872.3660	2022-05-02
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2019-04-30
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2021-12-14
KXR	Applicator, Resin	Dental	Class 1	872.3140	2019-04-30
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-08-09
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-08-09
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-08-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-08-09
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-02-21
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-02-21
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-02-21
EFN	Cotton, Roll	Dental	Class 1	872.6050	2019-04-30
IWZ	Film, Radiographic	Radiology	Class 1	892.1840	2026-06-18
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2022-12-08
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2019-04-30
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2021-06-11
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2019-07-10
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-05-07
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-05-07
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2025-05-07
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2026-03-09
LYY	Latex Patient Examination Glove	General Hospital	Class 1	880.6250	2020-02-13
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2021-06-08
FSO	Microscope, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4700	2025-08-19
DZI	Drill, Bone, Powered	Dental	Class 2	872.4120	2018-07-21
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2018-07-21
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2026-03-05
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2019-04-30
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-04-13
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2024-05-15
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2025-08-04
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2025-08-04
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2019-04-30
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2019-04-30
EHL	Point, Abrasive	Dental	Class 1	872.6010	2025-04-29
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2026-05-08
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-04-16
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2018-11-06
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2020-06-05
JES	Floss, Dental	Dental	Class 1	872.6390	2019-04-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2025-02-21
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-02-21
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2026-05-08
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2022-04-20
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2022-04-20
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2019-04-30
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2020-03-20
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2019-04-30
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2024-05-13
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2020-02-06
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2020-12-21
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2020-11-03
DZM	Needle, Dental	Dental	Class 1	872.4730	2025-05-21
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2019-04-30
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2021-08-10
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-11-17
KCR	Facebow	Dental	Class 1	872.3220	2023-05-18
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2025-07-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-07-31
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2023-05-15
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2026-06-18
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2019-04-30
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-11-20
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2021-01-21
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2025-07-31
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2022-04-20
EJP	Articulators	Dental	Class 1	872.3150	2024-08-08
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2018-11-06
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2025-08-11
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2019-07-10
FTS	Camera, Cine, Endoscopic, With Audio	General, Plastic Surgery	Class 1	878.4160	2024-07-02
ELW	Material, Impression	Dental	Class 2	872.3660	2026-03-27
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2025-12-04
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2025-06-25
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2022-04-20
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2019-04-30

Official Correspondent

Jianmin Yu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

JMU DENTAL, INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014683120. Last updated year: 2026. Please use registration number 3014683120 when referencing this establishment in official correspondence.