BEUDAMED
    FDA Registration Active 🇨🇿 Czechia

    SpofaDental a.s.

    Reg #: 3007743883 · FEI: 3007743883 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    145
    Establishment Types
    3
    Classifications
    10

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    Registration Details

    Registration Name
    SpofaDental a.s.
    Registration Number
    3007743883
    FEI Number
    3007743883
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Markova 238
    City
    Jicin Hradec Kralove
    Country
    CZ

    Regulatory Submissions

    510(k) Number
    K160441

    Owner / Operator

    Firm Name
    SYBRON DENTAL SPECIALTIES, INC.
    Operator Number
    9029565
    Address
    1889 W Mission Blvd, --
    City
    Pomona
    State
    CA
    Postal Code
    91766
    Country
    US
    Correspondent
    Jennifer Evans

    US Agent

    Business Name
    Sybron Dental Specialities Inc.
    Contact Name
    Jennifer Evans
    Address
    1717 West Collins Ave
    City
    Orange
    State
    CA
    ZIP
    92867
    Country
    US
    Email
    [email protected]
    Phone
    714 5167795

    Products

    Device Name Product Code
    Clamp, Rubber Dam EEF
    Material, Impression ELW
    Cord, Retraction MVL
    Retractor, All Types EIG
    Point, Abrasive EHL
    Disk, Abrasive EHJ
    Holder, Film, X-Ray EGZ
    Wax, Dental, Intraoral EGD
    Instruments, Dental Hand DZN
    Cement, Dental EMA

    Proprietary Names

    SoftClamp Take 1 Advanced Rigid Tray Take 1 Advanced GingiKNIT+ Nonimpregnated Retraction Cord GingiBRAID+ Nonimpregnated Retraction Cord GingiBRAID+ ShortCut Nonimpregnated Retraction Cord UniBRAID+ Nonimpregnated Retraction Cord KromaFaze Identic Integra Image Alignate Styptin Hemodettes GingiGEL Hemogin-L OptiView OptiView Premier Take 1 Advanced Putty GingiBRAID+ ShortCut Aluminum Potassium Sulfate Retraction Cord GingiBRAID+ Aluminum Potassium Sulfate Retraction Cord UniBRAID+ Aluminum Potassium Sulfate Retraction Cord GingiKNIT+ Aluminum Potassium Sulfate Retraction Cord Perfect Pearl and Petite Pearl Prophy Contra Angles and Brushes PORCELAIN / CERAMICS NG Polishers & Prepolishers Pro-Brush GlossPlus Polisher Cup MINIDENTOFLEX Right Angle Mandrel COMPOSITE Glanzpolierer IDF Rec.Gloss Polishers Flame Pin Spannhalter Occlubrush Assorted Kit PINIDENTOFLEX GOLD/PRECIOUS ME PINIDENTOFLEX Pin-Holder MAXI SUPER ACRYLIC POLISHERs IDF Rec.Gloss Polishers Disc Occlubrush Cups & Points HiLuster Plus Polisher cup COMPOSITE Polishers & Prepolishers Opti1Step Polishers DIAMOND COMPOSITE Polishers COMPOSITE Vorpolierer IDF Rec.Gloss Polishers Mini HiLusterPlus Assortment OptiShine OptiClean IDF Rec.Gloss Polishers Cup MINIDENTOFLEX -COMPOSITE Polishers & Prepolishers Hawe Bristle Brushes IDF Rec.HiLuster Dia Polishers Hawe Polishing Assorted Kit GOLD/ AMALGAM / PRECIOUS METAL Polishers NTI Acrylic Polisher Ultimate FG IntraOral Logic Set CeraGlaze Porcelain Polishing Logic Set Prophy Brushes Zir-Cut Polisher Logic Set Cera-Glaze Ultimate Porcelain Logic Set NTI Green Abrasive Pro-Cup Latch Type Soft DiaGloss Polishing Logic Set Zir-Cut Zirconia Polisher Ortho Adhesive Removal Logic Set Acrylic Adjustment Logic Set NTI DiaGloss Polisher NTI PDQ Polisher AXIS Laminate Veneer Set NTI Brown Abrasive NTI Silicone Polisher CeraGlaze Intra-Oral Polishing Logic Set Valplast Logic Set UltraGloss Composite Polishing Logic Set Porcelain Adjusting & Polishing Logic Set Polisher Century Pack CeraGlaze Porcelain Lab Logic Set Personalized Logic Set Razor Sculpt and Polishing Logic Set Shammy Bright Discs NTI White Abrasive NTI Pink Abrasive PDQ Composite Polishing Brush Logic Set NTI Goldstar E4D Chairside Dental Designer Logic Set NTI CeraGlaze NTI PDQ2 Polisher ProGloss Ultimate Composite Polishing Logic Set Goldstar Gold Polishing Logic Set E4D Preparation Logic Set Pro-Cup Junior, Latch Type, Standard PDQ2 Composite Polishing Logic Set E4D Sdjust & Polish Logic Set Bite Adjustment Logic Set Interdental Wedges Clinical CAD/CAM Preparation Logic Set Pro-Cup Junior, Screw-Type, Standard Pro-Cup, Screw-Type, Soft Composite Surface Treatment OptiDisc Hawe Testset X-Ray Kwik-Bite Digital Imaging & Accessories Super-Bite Super-Bite Senso Endo-Bite Senso Hawe Imaging Plate Holder Test Bite Wafer Disclosing Wax Occlusal Indicator Wax Take 1 Advanced Bite Impression Compound AlgiNot Hawe Interdental Wedges Double Plugger Unidose Gun Adapt Luciwedge Dispensing Gun Transparent Cervical Foils & Matrices Luciwedge Blue Transparent Molar & Premolar Bands Composite Filling Spatula Composite Instruments SuperMat Single-Dose Dispensing Gun Blue Cervical Matrices Cure-Thru Cervical Foils TCF-Holder Hawe Tofflemire Matrices Hawe Steel Band Hawe Contoured Tofflemire Band Perforation Repair Cervical Foil & Posterior Blue View Grip Strips Extruder Hand Plugger SuperCap Matrices & Spools Blue Cervical Foils Explorer Curette MetaFix Prophy Clip Stop Strips VPS Adhesive Nexus RMGI Breeze RMGI Image Alginate Dental Impression Materials Extrude

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device