LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K092412
    Device Name
    STRONG IMPLANT HANDPIECES
    Manufacturer
    SAESHIN PRECISION CO., LTD.
    Date Cleared
    2009-09-03

    (28 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K040674
    Why did this record match?
    Device Name :

    STRONG IMPLANT HANDPIECES

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

    The STRONG Implant Handpieces, ACL-411, ACL(B)-411, ACL-421, ACL(B)-421, ACL-431, ACL-(B)-431, ACL-451 and ACL(B)-451, are devices intended for a wide range of dental procedures including:

    • Endodontic surgeries, such as root canal preparations
    • Implant surgery such as perforating the bone, tapping and threading procedures
    • General dentistry such as removing carious material, cavity and crown preparation, finishing tooth preparations, restorations and polishing teeth
    Device Description

    The STRONG Implant Handpieces; ACL-411. ACL(B)-41I. ACL-421. ACL(B)-421. ACL-431. ACL-(B)-431. ACL-451 and ACL(B)-451. are gear driven hand-held dental handpieces with transmission ratio of 20:1, 16:1, 32:1 and 64:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 counling. A Saline inigation system for surgery treatment is integral to the STRONG Implant Handpieces. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

    AI/ML Overview

    This document is a 510(k) summary for the Saeshin STRONG Implant Handpieces, seeking clearance from the FDA. It does not include information about acceptance criteria or a study proving the device meets those criteria, as it's a submission for substantial equivalence based on a predicate device, not a performance study against specific criteria.

    Therefore, I cannot extract the requested information from the provided text. The document focuses on demonstrating that the STRONG Implant Handpieces are "substantially equivalent" to a legally marketed predicate device (ANTHOGYR Contra Angles and Handpieces, K040674) based on intended use, technology, claims, material composition, and performance characteristics, rather than reporting on a standalone study with defined acceptance criteria.

    The 510(k) process for this type of device typically involves demonstrating equivalence through comparisons of technical features, materials, and intended use, often citing compliance with recognized standards (like ISO 3964 and ISO 1797-1 as mentioned) without necessarily requiring a separate performance study with acceptance criteria as would be performed for novel devices or AI/software-as-a-medical-device (SaMD) clearances.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1