BEUDAMED
    Product Code: PLV FDA class 2 21 CFR 872.4120

    Dental Stereotaxic Instrument

    Dental

    The Dental Stereotaxic Instrument (product code PLV) is a Class 2 dental device intended to facilitate dental implant placement in patients who are partially edentulous or edentulous, regulated under 872.4120. It requires 510(k) clearance. The device itself is not an implant and is not life-sustaining; it serves as a surgical guidance instrument.

    View on FDA
    510(k)s
    23
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    4
    Years Active
    10

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    Basic Information

    Product Code
    PLV
    Device Class
    FDA class 2
    Regulation Number
    872.4120
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    To facilitate dental implant placement in patients that are partially endentulous or edentulous.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 23 510(k) clearances via K numbers.

    K Number Device Name
    K252376 Yomi S Robotic System
    K251835 Yomi Robotic System
    K233563 Navident
    K231018 Yomi Robotic System
    K210947 Navident
    K211466 Yomi Robotic System with YomiPlan Go
    K213392 INLIANT Surgical Navigation System
    K210711 Neocis Guidance System (NGS) with Yomi Plan v2.0.1
    K211129 Neocis Guidance System (NGS) with Intraoral Fiducial Array
    K203401 Neocis Guidance System (NGS) with Patient Splints (EPS)
    K202264 Neocis Guidance System (NGS) with Yomi Plan v2.0
    K202100 Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)
    K200805 Neocis Guidance System (NGS) with Patient Splints
    K200662 X-Guide® Surgical Navigation System
    K200348 Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
    K192579 X-Guide Surgical Navigation System
    K191363 Neocis Planning Software Application (NPSA) for 3rd Party PCs
    K191605 Neocis Guidance System (NGS)
    K182776 Neocis Guidance System
    K173402 Neocis Guidance System (NGS) with Chairside Splint
    K161399 Neocis Guidance System
    K161406 Navident
    K150222 X-Guide Surgical Navigation System

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.