BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DENTALEZ, INC., STARDENTAL DIVISION

    Reg #: 2520265 · FEI: 2520265 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    63
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    DENTALEZ, INC., STARDENTAL DIVISION
    Registration Number
    2520265
    FEI Number
    2520265
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1816 Colonial Village Ln
    City
    Lancaster
    State
    PA
    ZIP
    17601
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251701

    Owner / Operator

    Firm Name
    DENTALEZ, INC.
    Operator Number
    2513147
    Address
    301 Lindenwood Drive, Suite 100
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US

    Products

    Device Name Product Code
    Controller, Foot, Handpiece And Cord EBW
    Unit, Operative Dental EIA
    Handpiece, Air-Powered, Dental EFB
    Scaler, Ultrasonic ELC
    Curette, Periodontic EMS
    Spreader, Pulp Canal Filling Material, Endodontic EKK
    Plugger, Root Canal, Endodontic EKR
    Explorer, Operative EKB
    Handpiece, Direct Drive, Ac-Powered EKX
    Frame, Rubber Dam EJE
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS
    Scaler, Periodontic EMN
    Instrument, Diamond, Dental DZP
    Excavator, Dental, Operative EKC

    Proprietary Names

    Star E900 Electric System StarBright Dual Lamp Control System StarBright Single Lamp Control System LED Plug N Play Swivel Assembly 430 Torque HP 5-Hole Fiber Optic Swivel HiFlo Fiber Optic Swivel LED Swivel 4-line Non-Fiber Optic Swivel 2-line Non-Fiber Optic Swivel Star 440 Handpiece Star ETorque Electric Motor System - 265461, 265464, 265463, 268880 Titan Blis-sonic Scalers Lubricant, Electric HP Prophy Star 3 Handpiece - 264422 Prophy Star 3 SW Handpiece - 266281 DentaLube II - 262539 Hand Instrument - Curettes Hand Instrument - Spreaders Hand Instruments - Pluggers Hand Instruments Explorers - Endodontic 430 Series Lubricated High Speed Handpieces - 266154, 266183, 264451, 268861, 264951, 264952 430 Series Lube Free High Speed Handpieces - 266153, 266182, 262057, 262052, 268840, 264450, 268841 iStar Cordless Prophy Handpiece Visi-Frame Star E900 1:1 Straight, Handpiece - 266345 Star E900 1:5 Auto Chuck, Fiber Optic Handpiece - 266342 Star E900 1:5 Auto Chuck, Non-Fiber Optic, Handpiece - 266490 Star E900 1:1 Auto Latch, Fiber Optic Handpiece - 266343 ETorque Handpieces - 265471, 265472, 265473, 265474, 265475 Star 500 Swivel, non-Fiber Optic Star 500 Elite Handpiece, Lubricated non-Fiber Optic Star 500 Swlvel, Fiber Optic Star 400 Flex Handpiece, Lubricated, Fiber Optic Star 500 Elite Handpiece, LubeFree, non-Fiber Optic Star 500 Elite Handpiece, LubeFree, Fiber Optic Star 500 Elite Handpiece, Lubricated, Fiber Optic Star 400 Flex Handpiece, Lubricated, non-Fiber Optic Star 400 Flex Handpiece, LubeFree, non-Fiber Optic Star 400 Flex Handpiece, LubeFree, Fiber Optic Hand Instruments - Scalers 430 SWL 45 Handpiece - 265821 430 SW 45 Handpiece - 265822 Concentrix MX Handpiece - 265630 Simplicity FX Handpiece - 265634 Classique Diamond Burs Titan EX Angles Titan EX Attachments Titan EX Motor 20K Titan-E 20K Motor Star Titan 20K Motor SW Star Titan 20K Motor FX Star Titan 5K Motor FX Titan 3 Motors Star Titan 5K Motor SW Titan 3 Lubricated Angles Titan 3 Lubefree Angles Titan-T Lubefree Angles Titan 3 Attachments Titan-T Attachments Titan-T Lubricated Angles Titan-T Motors Hand Instruments - Excavators

    Establishment Types

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