BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GoldenDent

    Reg #: 3005972890 · FEI: 3005972890 · Expires 2026
    View on FDA
    Products
    39
    Proprietary Names
    41
    Establishment Types
    2
    Classifications
    39

    Registration Details

    Registration Name
    GoldenDent
    Registration Number
    3005972890
    FEI Number
    3005972890
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    27251 Gratiot Ave
    City
    Roseville
    State
    MI
    ZIP
    48066
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210367

    Owner / Operator

    Firm Name
    GoldenDent
    Operator Number
    9090600
    Address
    27251 Gratiot Ave., --
    City
    Roseville
    State
    MI
    Postal Code
    48066
    Country
    US

    Products

    Device Name Product Code
    Handle, Instrument, Dental EJB
    Pin, Retentive And Splinting, And Accessory Instruments EBL
    Reamer, Pulp Canal, Endodontic EKP
    Laser, Dental, Soft Tissue NVK
    Lamp, Infrared, Therapeutic Heating ILY
    Powered Laser Surgical Instrument GEX
    File, Pulp Canal, Endodontic EKS
    Forceps, General & Plastic Surgery GEN
    Mirror, Mouth EAX
    Accessories, Implant, Dental, Endosseous NDP
    Scaler, Periodontic EMN
    Elevator, Surgical, Dental EMJ
    Point, Paper, Endodontic EKN
    Scissors, General, Surgical LRW
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Post, Root Canal ELR
    Forceps, Tooth Extractor, Surgical EMG
    Radiographic Protective Glove IWP
    Activator, Ultraviolet, For Polymerization EBZ
    System, X-Ray, Extraoral Source, Digital MUH
    Handpiece, Direct Drive, Ac-Powered EKX
    Accessories, Retractor, Dental EIF
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Syringe, Periodontic, Endodontic, Irrigating EIC
    Gutta-Percha EKM
    Instrument, Manual, Surgical, General Use MDM
    Retractor, All Types EIG
    Bur, Dental EJL
    Locator, Root Apex LQY
    Retainer, Matrix JEP
    Scaler, Ultrasonic ELC
    Drill, Bone, Powered DZI
    Airbrush KOJ
    Instruments, Dental Hand DZN
    Plugger, Root Canal, Endodontic EKR
    Instrument, Contouring, Matrix, Operative EKF
    Controller, Foot, Handpiece And Cord EBW
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS

    Proprietary Names

    WagoTrix Wedge GoldenDent Laser LX16 and accessories Golden-Taper Flex Series dental mirror Wam Key, MD Guide Spotter Separators GMX 69, Distal Elevator, Buccal Elevator, Lingual Elevator, The Wedge, The Reflector, Cowhorns GoldenDent Sutures GoldenForce X-Ray Protective Surgical Gloves O-Star Curing Light X-Star Curing Light O-Star Pro Curnig Light X-Ray Endo Motor Vibraject; Vibraject Clip Brackets, Vibraject Motor and Housing, Vibraject Control Knob PT-S1, PT-S3 / SANDBLASTING POWDER Irriflex Endo Irrigation Physics Forceps SeeMore GoldenDent Bur Kit APEX Locator WagoTrix Matrix Into Kit WagoTrix Sectional Matrix System; Class W; Class X WagoTrix Universal Matrix Ring Anatomical Matrix Piezo Implant Motor PTA Quick Connect Intro Kit Deep Margin Elevation Wedge Quick Connect Anatomy Band physics forceps separator Wedge FlashMax Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E, Plugger Wagotrix Wagotrix Sectional Matrix System Dental Electric Motor, MT2, MT3, Controller Foot, Handpience and Cord, Contra and Right Angle attachment

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility