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510(k) Data Aggregation

    K Number
    K162028
    Device Name
    PREMIUM - SHELTA Prosthetic Components
    Manufacturer
    SWEDEN & MARTINA S.p.A.
    Date Cleared
    2017-03-24

    (245 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Abutments:

    PREMIUM-SHELTA Conico Abutments are intended to be used in conjunction with a PREMIUM-SHELTA Implants Systems in fully edentulous or partially edentulous maxillary and/or mandibular arches.

    The PREMIUM-SHELTA Conico Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit the abutment screw is intended to secure the abutment to the endosseous implant.

    PREMIUM-SHELTA Conico Abutments are compatible with PREMIUM-SHELTA Implants Systems. Anchorage of dentures retained by taper friction and supported by PREMIUM-SHELTA Implants Systems.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental prosthetic component. It confirms that the device, "Premium Shelta Prosthetic Components," is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory approval, not a technical report on performance validation.

    Therefore, I cannot provide the requested information based on the given text.

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