BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ONE SYSTEM TAPERED TITANIUM ABUTMENTS

    K Number: K925349 · Decision Jul 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    10
    Review Days
    278

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    Basic Information

    Device Name
    ONE SYSTEM TAPERED TITANIUM ABUTMENTS
    K Number
    K925349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Implant Support Systems, Inc.
    Date Received
    October 22, 1992
    Decision Date
    July 27, 1993
    Product Code
    NHA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NHA Abutment, Implant, Dental, Endosseous

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    Other Clearances by Implant Support Systems, Inc.

    K Number Device Name
    K933532 SELF TAPPING DENTAL IMPLANT SYSTEM
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    K925312 HAND INSTRUMENT CALCULUS REMOVAL
    K925313 TITANIUM COC ABUTMENT HEADS FOR IMZ
    K924190 ISS O-RING ATTACHMENT
    K921764 DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS
    K904605 TITANIUM COC ABUTMENT HEADS FOR IMZ
    K895986 PRECISION DENTAL ATTACHMENTS
    K892239 DENTAL HAND INSTRUMENTS