BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SUNSTAR AMERICAS, INC.

    Reg #: 1413787 · FEI: 1413787 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    82
    Establishment Types
    3
    Classifications
    10

    Registration Details

    Registration Name
    SUNSTAR AMERICAS, INC.
    Registration Number
    1413787
    FEI Number
    1413787
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    301 East Central Road
    City
    Schaumburg
    State
    IL
    ZIP
    60195
    Country
    US

    Regulatory Submissions

    510(k) Number
    K950993

    Owner / Operator

    Firm Name
    Sunstar Americas, Inc.
    Operator Number
    9016423
    Address
    301 E Central Rd
    City
    Schaumburg
    State
    IL
    Postal Code
    60195
    Country
    US
    Correspondent
    Paula Wendland

    Products

    Device Name Product Code
    Mirror, Mouth EAX
    Explorer, Operative EKB
    Wax, Dental, Intraoral EGD
    Toothbrush, Manual EFW
    Cup, Prophylaxis EHK
    Pick, Massaging JET
    Floss, Dental JES
    Scaler, Periodontic EMN
    Scraper, Tongue LCN
    Toothbrush, Powered JEQ

    Proprietary Names

    G-U-M Lighted Mirror GUM Oral Care Cleaning Kit (EXPLORER, OPERATIVE) GUM® Orthodontic Wax +Vitamin E GUM® Orthodontic Wax Mint with Vitamin E and Aloe Vera PROPHYCIENCY BUTLER DUROPRO MONSTERZ EEZ-TOUCH GUM® Proxabrush Interdental Brush 1.2mm GUM® Proxabrush Interdental Brush 1.4mm GUM® Proxabrush Interdental Brush 1.6mm GUM® Proxabrush Interdental Brush 0.8mm GUM® Proxabrush Interdental Brush 0.6mm TRAV-LER GUM® Proxabrush Interdental Brush 1.3mm GUM® Proxabrush Interdental Brush 1.1mm GUM® SOFT-PICKS® Original GUM® SOFT-PICKS G-U-M Gum Stimulator G-U-M Gum Stimulator Refills BUTLERWEAVE CRAYOLA Eez-Thru G-U-M Floss Threaders FLOSSMATE Handle FLOSSBRUSH BUTLER Floss GUM® Floss DEEP CLEAN EXPANDING BARBIE PROFESSIONAL CLEAN PLUS LADY BUG DUAL-DEFENSE GUM® ECO FLOSSER COMFORT SLIDE Twisted Mint FINE ProWeave GUM® Original Flossers PROFESSIONAL CLEAN ADVANCE CARE GUM® Mint Floss TROLLS AVENGERS Kids Flossers GUM® Advanced Care Flossers Crayola®™ Twistables™ Kid's Flossers GUM Oral Care Cleaning Kit (SCALER, PERIODONTIC) G-U-M Tongue Scraper Dual Action Tongue Cleaner CRAYOLA Power Toothbrush BARBIE Power Toothbrush GUM® Sonic Powered Toothbrush Heads GUM® Denticare Toothbrush GUM® Sponge Bob Kids Travel toothbrush GUM® Technique Kids Toothbrush GUM® CRAYOLA Marker Toothbrush Dome Trim SUPER TIP MICRO TIP TECHNIQUE MAXMASSAGE GUM® PAW PATROL Toothbrush Denture GUM® Multi-Clean Toothbrush GUM® End-Tuft Toothbrush GUM® Travel ToothBrush Tooth and Tongue GUM® Kids Sponge Bob Manual Toothbrush GUM® Ortho Travel Toothbrush GUM® Original White Toothbrush GUM® Hot Wheels Toothbrush GUM® Paw Patrol Kids Travel toothbrush GUM® Technique Esmalte Clean Toothbrush GUM® Bright Care Toothbrush GUM® Classic Toothbrush GUM® Suave Toothbrush TROLLS Manual Toothbrush GUM® Technique Enamel Clean Toothbrush GUM® Paw Patrol Light Up Toothbrush GUM® Junior MONSTERZ Manual Toothbrush (5+)

    Establishment Types

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