BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AntiSplatr Flex Slim Disposable Prophy Angle, 90 Degree, Flex Cup, 200ct

    Reg #: 2086043 · FEI: 3000719964 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PAC-DENT INC.
    Registration Number
    2086043
    FEI Number
    3000719964
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    670 Endeavor Circle
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030603

    Owner / Operator

    Firm Name
    Pac-Dent Inc.
    Operator Number
    10056434
    Address
    670 Endeavor Cir
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    Tom Peng

    Products

    Device Name Product Code
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS

    Proprietary Names

    AntiSplatr Flex Slim Disposable Prophy Angle, 90 Degree, Flex Cup, 200ct Freestyle Pro ProMate ProAngle ProMate™ EZ-Q Quick Disconnect Hygiene Handpiece AntiSplatr™ Disposable Prophy Angles ProMate™EZ-Q Quick Disconnect Coupler ProMate™ EZ-Q Quick Disconnect Combo- Hygiene Handpiece and Coupler ACCLEAN ERGO PROPHY ANGLE LF AntiSplatr Flex Slim disposable Prophy Angle Bulk Pack, 90 Degree, Flex Cup, 1,200ct AntiSplatr Flex Ergo Slim Disposable Prophy Angle, Contra Angle, Flex Cup, 200ct AntiSplatr Flex Ergo Slim Disposable Prophy Angle Bulk Pack, Contra Angle, Flex Cup, 1,200ct

    Establishment Types

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