BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    POLYDENTIA S.A.

    Reg #: 8031054 · FEI: 1000558210 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    71
    Establishment Types
    2
    Classifications
    7

    Registration Details

    Registration Name
    POLYDENTIA S.A.
    Registration Number
    8031054
    FEI Number
    1000558210
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    VIA CANTONALE 47
    City
    MEZZOVICO-Vira Ticino
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K790555

    Owner / Operator

    Firm Name
    Polydentia S.A.
    Operator Number
    9076845
    Address
    Via Cantonale 47
    City
    Mezzovico- Vira
    State
    Ticino
    Postal Code
    CH-6805
    Country
    CH

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Instruments, Dental Hand DZN
    Dispenser, Liquid Medication KYX
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Post, Root Canal ELR
    Accessory, Surgical Apparel LYU
    Point, Abrasive EHL

    Proprietary Names

    Hemo-Wedge Macro-Wedges HY-DROP Hy-Drop Forte Vista-Tec Ultralight Matrices Diamond 24 myQuickmat Classico starter kit Stop-Card Unica anterior matrices LumiContrast myTines Small Refill Maximat Plus Wedges myTines Large Refill ID-Rings clip&Splint myTines Medium Refill Endo-Stops myQuickmatrix forceps Junior Quickmat sectional matrices myQuickmat All-round introkit Junior LumiContrast Sectional Matrices myTines Refill Quickring Forceps Interdental Wood Wedges Unica minideep anterior myTines Junior Refill myQuickmat Forte starter kit API autoclavable placement instrument Maxi ID-Rings myJunior Kit QuickmatFLEX Unica anterior introkit Quickmat Deluxe Kit Cotton Roll Holder myRing Junior QuickmatFIT myForceps Quickmat All-round Quickmat Prime 3wedge myClip 2 Unica Proximal myQuickmat classico kit myQuickmat Prime kit The Wedge myWedge myRing classico myClip Junior myTines GO myTines Prime Unica Proximal Deep myRing Prime Unica master kit Fiber-Splint Lab Ret Fiber-Splint ML Mini Starter Kit Fiber-Bond Fiber-Splint Lab Bridge Fiber-Plast Fiber-Splint Ortho Evolution Fiber-Splint ML Multy-Layer Fiber-Splint F-Splint-Aid Slim F-Splint-Aid Fiber-Splint Ortho Fiber-Splint Lab- System Polydentia GF Posts Vista-Tec iIGrande; Vista-Tec laStoria; Vista-Tec Tria-Shine Abrasive Polishing Strip

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device