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510(k) Data Aggregation

    K Number
    K180365
    Device Name
    PRAMA White Implant Systems
    Manufacturer
    Sweden & Martina S.p.A.
    Date Cleared
    2019-07-08

    (511 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRAMA White Implant Systems

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PRAMA White Implant Systems are intended for both one- and two-stage surgical procedures. PRAMA White Implant Systems, endosseous implant and abutments, are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. PRAMA White Implant Systems are intended to be used in fully edentulous or partially edentulous maxillary and/or mandibular arches.

    Device Description

    Not Found

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a dental implant system (PRAMA White Implant Systems), which primarily details the regulatory approval of the device and its intended use.

    Therefore, I cannot provide the requested information.

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