BEUDAMED
    FDA Registration Active 🇺🇸 United States

    JMU DENTAL, INC

    Reg #: 3014683120 · FEI: 3014683120 · Expires 2026
    View on FDA
    Products
    138
    Proprietary Names
    194
    Establishment Types
    1
    Classifications
    138

    Registration Details

    Registration Name
    JMU DENTAL, INC
    Registration Number
    3014683120
    FEI Number
    3014683120
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    150 E Lambert Rd
    City
    Fullerton
    State
    CA
    ZIP
    92835
    Country
    US

    Regulatory Submissions

    510(k) Number
    K220831

    Owner / Operator

    Firm Name
    JMU DENTAL, INC
    Operator Number
    10058141
    Address
    150 E Lambert Rd
    City
    Fullerton
    State
    CA
    Postal Code
    92835
    Country
    US
    Correspondent
    Jianmin Yu

    Products

    Device Name Product Code
    Gown, Examination FME
    Handpiece, Rotary Bone Cutting KMW
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Controller, Foot, Handpiece And Cord EBW
    Material, Impression ELW
    Finger Cot LZB
    Cap, Surgical FYF
    Tray, Impression, Preformed EHY
    Tube, Orthodontic DZD
    Wrap, Sterilization FRG
    Bedpan FOB
    Accessories, Retractor, Dental EIF
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Forceps, Rongeur, Surgical EMH
    Tape And Bandage, Adhesive KGX
    Polymer Patient Examination Glove LZA
    Chair, Adjustable, Mechanical INN
    Loupe, Binocular, Low Power HJH
    Paper, Articulation EFH
    Indicator, Physical/Chemical Sterilization Process JOJ
    Handpiece, Direct Drive, Ac-Powered EKX
    Locator, Root Apex LQY
    Syringe, Cartridge EJI
    Mirror, Mouth EAX
    Scissors, Surgical Tissue, Dental EGN
    Handpiece, Air-Powered, Dental EFB
    Scaler, Ultrasonic ELC
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Point, Paper, Endodontic EKN
    Tube Impression And Matrix KCQ
    Chair, Dental, Without Operative Unit NRU
    System, X-Ray, Extraoral Source, Digital MUH
    Light, Microscope IBJ
    Instrument, Diamond, Dental DZP
    Tourniquet, Nonpneumatic GAX
    Scissors, General, Surgical LRW
    Cleaner, Ultrasonic, Medical Instrument FLG
    Gauze / Sponge,Nonresorbable For External Use NAB
    Depressor, Tongue, Non-Surgical FMA
    Negative Pressure Wound Therapy Powered Suction Pump OMP
    Handle, Instrument, Dental EJB
    Holder, Film, X-Ray EGZ
    Gutta-Percha EKM
    Powder, Porcelain EIH
    Elevator, Surgical, Dental EMJ
    Applicator, Absorbent Tipped, Sterile KXG
    Retainer, Surgical GCZ
    Tip, Rubber, Oral Hygiene JEW
    Stool, Operating-Room FZM
    Tray, Surgical, Instrument FSM
    Retractor, All Types EIG
    Unit, Syringe, Air And/Or Water ECB
    Positioner, Tooth, Preformed KMY
    Non-Surgical Gown OEA
    Mask, Surgical FXX
    Cutter, Wire HXZ
    Plugger, Root Canal, Endodontic EKR
    Dispenser, Liquid Medication KYX
    Accessories, Implant, Dental, Endosseous NDP
    Applicator, Resin KXR
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Medical Glove, Specialty LZC
    Fentanyl And Other Opioid Protection Glove QDO
    Cotton, Roll EFN
    Film, Radiographic IWZ
    Heat Source For Bleaching Teeth EEG
    Chair, Examination And Treatment FRK
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Latex Patient Examination Glove LYY
    Strip, Polishing Agent EHM
    Microscope, Surgical, General & Plastic Surgery FSO
    Drill, Bone, Powered DZI
    Container, Sharps MMK
    Absorber, Saliva, Paper KHR
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Catheter, Irrigation GBX
    Instrument, Filling, Plastic, Dental EIY
    Camera, Television, Endoscopic, Without Audio FWF
    Point, Abrasive EHL
    Retainer, Screw Expansion, Orthodontic DYJ
    Pack, Hot Or Cold, Disposable IMD
    Spring, Orthodontic ECO
    Band, Preformed, Orthodontic ECM
    Floss, Dental JES
    Clamp, Wire, Orthodontic ECN
    Mouthpiece, Saliva Ejector DYN
    Plier, Orthodontic JEX
    Carver, Dental Amalgam, Operative EKH
    Mixer, Cement, For Clinical Use JDZ
    File, Pulp Canal, Endodontic EKS
    Band, Elastic, Orthodontic ECI
    Forceps, Dressing, Dental EFL
    Needle, Dental DZM
    Toothbrush, Manual EFW
    Basin, Emesis FNY
    Facebow KCR
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Material, Tooth Shade, Resin EBF
    Blade, Scalpel GES
    Syringe, Restorative And Impression Material EID
    Accessory, Surgical Apparel LYU
    Agent, Tooth Bonding, Resin KLE
    Wax, Dental, Intraoral EGD
    Articulators EJP
    Bracket, Metal, Orthodontic EJF
    Spreader, Pulp Canal Filling Material, Endodontic EKK
    Material, Impression Tray, Resin EBH
    Camera, Cine, Endoscopic, With Audio FTS
    Light, Operating, Dental EAZ
    Retainer, Matrix JEP
    Depressor, Metal Tongue, Surgical KBL
    Cup, Prophylaxis EHK
    Denture, Plastic, Teeth ELM
    Unit, Suction Operatory EBR
    Dental Barriers And Sleeves PEM
    Activator, Ultraviolet, For Polymerization EBZ
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Dynamometer, Nonpowered HRW
    Cover, Shoe, Operating-Room FXP
    Mask, Scavenging KHA
    Wire, Orthodontic DZC
    Forceps, Tooth Extractor, Surgical EMG
    Protector, Dental BRW
    Setter, Band, Orthodontic ECR
    Dressing, Compression MHW
    Evacuator, Oral Cavity EHZ
    Cement, Dental EMA
    Dam, Rubber EIE
    Bur, Dental EJL
    Screwdriver HXX
    Container, Specimen, Non-Sterile NNI
    Unit, Operative Dental, Accessories NRD
    Loupe, Diagnostic/Surgical FSP
    Dispenser, Solid Medication NXB
    Tray, Surgical, Ent MMO
    Clamp, Rubber Dam EEF
    Scraper, Tongue LCN
    Instruments, Dental Hand DZN

    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 LED Whitening Light, LED Curing Light Handpiece, direct drive, ac-powered CHAIR, EXAMINATION AND TREATMENT 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. 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 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 RESIN Orthodontic Wax Articulator Gutta Percha Pluggers EVACUATOR, ORAL CAVITY Intraoral Camera A-Silicone Bite Registration Material JMU Dental LED Light Tongue Depressor Prophy Angles; Prophy Brushes; Prophy Cups; Disposable Prophy Angles; Disposable Prophy Cups Synthetic Polymer Teeth C-AS1 Plastic Chair Cover, Tray Cover, Syringe Sleeves Intraoral Scanner Disposable Protective Shoes Cover, Disposable Sleeve Cover LED Curing Light FACE MASK FORCEPS, TOOTH EXTRACTOR, SURGICAL Retainer storage case Premium Latex Examination Gloves cheek retractor Gauze Bandage Rolls TRAY, SURGICAL, INSTRUMENT dental composite, resin, cement JMU Natural Latex Dental Rubber Dam BUR, DENTAL SCREWDRIVER Whitening Gel Emesis Bag AIR COMPRESSOR AND VACUUM UNIT; BARRIER FILM; HANDPIECE SLEEVES; INSTRUMENT TRAY SLEEVES; LIGHT/SENSOR SLEEVES/ POUCHES; BARRIER SLEEVES; SURRINGE SLEEVES; DENTAL TRAY COVER, HEADREST COVER, INTRAORAL CAMERA SHEATH Imaging Plate Scanner DENTAL LOUPES Dental Bib Holder/Dispenser Instrument Disinfection Box Dental Dam Apex Locator DPEX III Tongue Cleaner Dental hand instrument

    Establishment Types

    Repack or Relabel Medical Device