LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K251614

    Validate with FDA (Live)

    Device Name
    Stainless Steel Surgical Kits
    Manufacturer
    Dentsply Sirona, Inc.
    Date Cleared
    2026-02-06

    (255 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    All
    Reference & Predicate Devices
    K231144,K212068,K220791
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K231144, K212068

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

    The Stainless Steel Surgical Kits are intended for organizing, sterilizing and storing of drills, instruments, and prosthetic accessories.
    The Stainless Steel Surgical Kits are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.

    Sterilization parameters

    • Pre-vacuum Steam at 132 °C (270 °F) for 4 minutes with a 20 minute dry time.
    • Do not exceed the worst-case validated maximum load:
    Item NumberProduct NameDimensions (inch)Max Load (gr)Vent to Volume Ratio (inch-1)Kit type
    MK-0020Bone compression kit3.94x3.46x1.86318.770.15Closed
    MK-0056Scan post Int. Hexagon connection Kit2.60x2.83x1.02143.590.29Closed
    MK-0057Scan post Conical connection Kit2.60x2.83x1.02146.320.29Closed
    MK-0059Bone profiler Int. Hex. kit2.79x1.18x1.7779.2610.18Open
    MK-0060Bone profiler coni. con. kit2.79x1.18x1.7781.0010.18Open
    MK-0065Scan post organizer box2.60x2.83x1.02146.320.29Closed
    MK-BC101Drill stopper kit for C1 implant, SP2.60x2.83x1.02144.870.29Closed
    MK-BS001Drill stopper kit for Seven implant, SP2.60x2.83x1.02144.640.29Closed
    MK-CDS08Drill stopper kit for 8mm length C1 implant procedure1.97x2.83x1.02117.270.26Closed
    MK-CDS10Drill stopper kit for 10mm length C1 implant procedure1.97x2.83x1.02116.700.26Closed
    MK-CDS11Drill stopper kit for 11.5mm length C1 implant procedure1.97x2.83x1.02116.280.26Closed
    MK-CDS13Drill stopper kit for 13mm length C1 implant procedure1.97x2.83x1.02115.860.26Closed
    MK-LDSKLance Drill stoppers kit4.22x3.96x1.20282.170.20Closed
    MK-SDS06Drill stopper kit for 6mm length Seven implant procedure1.97x2.83x1.02118.430.26Closed
    MK-SDS08Drill stopper kit for 8mm length Seven implant procedure1.97x2.83x1.02117.190.26Closed
    MK-SDS10Drill stopper kit for 10mm length Seven implant1.97x2.83x1.02116.640.26Closed
    MK-SDS11Drill stopper kit for 11.5mm length Seven implant procedure1.97x2.83x1.02116.220.26Closed
    MK-SDS13Drill stopper kit for 13mm length Seven implant procedure1.97x2.83x1.02115.810.26Closed
    Device Description

    The Stainless Steel Surgical Kits are reusable containers that are used to store and organize drills, instruments, and prosthetic accessories needed before, during and after the implantation and the prosthetic procedure.

    The Stainless Steel Surgical Kits are also designed to hold the drills, instruments, and prosthetic accessories during the sterilization process. The kits are intended to be used in conjunction with a legally marketed, validated sterilization pouch that is intended to maintain sterility of the items placed inside the kits.

    The proposed Stainless Steel Surgical Kits must be cleaned and sterilized before the first use and after each use according to the Instructions for Use (IFU) included with each kit.

    The proposed Stainless Steel Surgical Kits can be divided into two types of kits: Open and Closed Kits.

    Open kits consist of a lid and base with holders. Open kits cannot be closed with a lid to cover the items, but contain a lid that is always open and can be moved to a horizontal position. Open kits also do not contain an insert; the instrument holders are integrated on the base of the kit. In addition, in Open kits, the base is open and the holders can be seen through the bottom of the base.

    By contrast, Closed kits consist of a lid, removable insert with holders, and base. Closed kits have a lid that can be closed. The lid has perforations that allows for steam penetration. In addition, one of the proposed Closed kits also contains a removable bath. The bath is used to hold soiled items after use during the surgical procedure.

    The lid, base, insert, and bath of these kits are made of stainless steel. Silicone holders hold the kit components in each surgical kit. The role of the holders is to properly hold the items during transportation, sterilization and before use by the dentist.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1