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510(k) Data Aggregation

    K Number
    K243066
    Device Name
    Dental Implants and Abutments
    Manufacturer
    Ditron Dental LTD
    Date Cleared
    2024-12-16

    (80 days)

    Product Code
    DZE,NHA,PRI
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K161497,K233231,K163194,K191191,K072878,K130808,K140728
    Why did this record match?
    Reference Devices :

    K161497, K233231, K163194, K191191, K072878, K130808

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

    Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the chewing function of patients with fully or partially edentulous:

    • Two stages: MPI, ULT, API, CPI, MPC, APC, CPC and UPC models .
    • . One stage: OPI and TPI models

    The 3.3mm and 3.0mm diameter implants (OPI and TPI. MPI and API) are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple implants.

    The Two stages and One stage implants are indicated for temporary or long-term use. They are selftapping titanium threaded screws indicated for long term intra bony applications. They permit immediate splint stability and long-term fixation of new or existing crown, bridge and prosthesis and protection of graft sites.

    MPI, ULT, API, CPI, OPI, TPI, MPC, APC, CPC and UPC models are indicated for immediate loading (except for MPI. and API 6mm length) in single- and multi-tooth restoration, when good primary stability is achieved and with appropriate occlusal loading.

    The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration.

    The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.

    The Temporary Titanium and PEEK Abutments are indicated to be used on Ditron implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

    Device Description

    This submission covers changes related to Ditron's Dental implants and abutments. The inclusion of additional product variations aims to provide dental surgeons with a broader range of implant and abutment options for patient treatment.

    The requested additions to Ditron's Dental Implants and Abutments within this 510(k) are hereby described:

    . An additional implant types:

    • MPC (Conical Connection Molecular Precision Implant) o
    • O APC (Conical Connection Advanced Precision Implant)
    • UPC (Conical Connection Ultimate Precision Implant) O
    • CPC (Conical Connection Cylindrical Precision Implant) O

    The Conical Connection (CC) implants include a conical connection platform (Morse taper). The intended use, materials, drilling protocol, thread designs and bone interface of the subject Conical Connection implants (MPC, UPC, APC and CPC) are identical to Ditron's cleared Internal Hex connection platform implants (MPI, ULT, API and CPI, respectively). The CC implants include color anodization for aesthetic purposes. The CC compatible Cover and Prosthetic Screws are color anodized as well.

    The MPC/APC/CPC/UPC Implants are available in diameters of 3.5mm, 4.2mm, 5.0mm, and 6.0mm, with lengths of 8.0mm, 11.5mm, 12mm, 13mm, 14mm, and 16mm. Additionally, a 6.5mm length is offered for MPC/APC/CPC implants in 4.2mm, 5.0mm, and 6.0mm diameters, and a 7.0mm length is available for UPC implants in 4.2mm, 5.0mm, and 6.0mm diameters.

    • An additional Abutment type: CC Healing Caps and SRA Healing Caps Abutments The CC Healing Caps are color-anodized for aesthetic purposes. They are used for the maintenance of the soft tissue during the osseointegration phase of Ditron CC implants to be rehabilitated using technique. They are available in diameters of 3.5, 4.5 and 5.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5 and 4.5mm.
    • An additional Abutment type: CC Cement Retained Abutments the CC Anatomic/Universal . straight/angulated abutments are Cement-Retained Abutments. They are intermediary prosthetic components to be installed onto Ditron's CC implants to support the final prosthesis. They are available as straight (0°) or angulated (15° and 25°) in diameters: 3.5, 4.5 and 5.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5 mm.
    • . An additional Abutment type: CC Single-Unit and Multi-Unit Abutments - The CC Screw-retained Single Unit Abutment and Multi Unit Abutments are intermediary prosthetic components to be installed onto CC Ditron's implants to support the final prosthesis. They are available as straight (0°) or angulated (17° and 30°) and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.0 mm. The Single Unit abutment height is up to 4.5mm only.
    • An additional Abutment type: CC Temporary Titanium Abutments The CC Temporary Titanium Abutments are temporary intermediary prosthetic components to be installed onto the Ditron's CC implants to support the provisional prosthesis for up to 6 months. They are available as straight (0°) in diameters: 3.5 and 4.5mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5mm.
    • An additional Abutment type: CC Temporary PEEK Abutments The CC Temporary PEEK Abutments are temporary intermediary prosthetic components to be installed onto Ditron's CC implants to support the provisional prosthesis for up to 6 months. They are composed of a customizable cylindrical body made of PEEK and a non-customizable base made of titanium. They are available in diameters of 4.5 and 6.0mm and the following gingival heights: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5mm.
    • An additional Abutment type: CC Liberator Overdenture Abutment The CC Liberator Overdenture Abutment is similar in design to Ditron's cleared Liberator abutment, except for the addition of Titanium Nitride (TiN) coating on the subject device. It is available in the following gingival heights: 0.5, 1.0, 2.0, 3.0, 4.0, 5.0 and 6.0mm.
    • An additional Abutment type: SRA Titanium Coping Abutments The SRA Titanium Coping . Abutment is suitable for use with the CC Screw-retained single Abutments. It connects to the abutment using one of the designated abutment screws. They are available in short (L4.85mm) and long (L11mm) versions.
    • Modification to Cleared Titanium Abutments Addition of Laser Marking for identification as an option for all of the Ditron Dental cleared Titanium Abutments (K140728, K161497, K233231).
    • Modification to Cleared Liberator and TPI Overdenture Abutments Addition of TiN coating to . Ditron's cleared Liberator abutment (K161497) and the cleared TPI Liberator Overdenture Abutment (K233231).
    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is a 510(k) summary for Dental Implants and Abutments, focusing on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data. It does not mention any AI/ML components or related studies.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts and their qualifications for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results (effect size).
    6. Standalone performance study for an algorithm.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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    K Number
    K242261
    Device Name
    Accelx Implant System
    Manufacturer
    Biotech Dental LLC
    Date Cleared
    2024-11-06

    (98 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K203240,K233231,K110955
    Why did this record match?
    Reference Devices :

    K203240, K233231, K110955

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

    Accelx Implant System implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Accelx Implant System implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant diameters larger than 6.0 mm are dedicated for the molar region and are indicated for delayed loading.

    Accelx Implant System implants are compatible with Accelx Implant System abutments.

    Accelx Implant System implants are compatible with MegaGen AnyRidge Internal Implant System titanium abutments as listed below.

    Implant System CompatibilityPlatform Diameter, mmMaximum Angulation
    MegaGen AnyRidge Internal Implant System3.5, 4.0, 4.25, 5.025°

    Accelx Implant System cover screws are compatible with MegaGen AnyRidge Internal Implant System components as listed below.

    Implant System CompatibilityImplant Body Diameter, mmImplant Platform, mm
    MegaGen AnyRidge Internal Implant System4.03.5
    4.43.5
    4.93.5, 4.0
    5.43.5, 4.25
    5.93.5, 4.25
    6.45.0
    6.95.0
    7.45.0
    7.95.0
    8.45.0
    Device Description

    The Accelx Implant System comprises Accelx dental implants, Accelx abutments previously cleared in K203240. The Accelx Implant System is compatible with the MegaGen AnyRidge Internal Implant System, regardless of the implant platform; this compatibility is due to the internal taper connection.

    Accelx dental implants have an internal taper abutment interface connection and an internal hexagonal feature for abutment anti-rotation and instrument. The internal threaded section is for mating to the corresponding Accelx cover screws, abutments and screws previously cleared in K203240, and MegaGen AnyRidge Internal Implant System restorative devices.

    Accelx dental implants are provided in ten body diameters ranging from 4.0 mm to 8.4 mm, and in total lengths ranging from 7.7 mm to 14.2 mm. Implants with a body diameter of 4.0 mm and 4.4 mm have a platform diameter of 3.5 mm. Implants with a body diameter of 4.9 mm have a platform diameter of 3.5 mm or 4.0 mm. Implants with a body diameter of 5.4 mm to 5.9 mm have a platform diameter of 3.5 mm. Implants with a body diameter of 6.4 mm to 8.4 mm have a platform diameter of 5.0 mm. The implants are manufactured from titanium alloy conforming to ASTM F136. The endosseous surface of the implant is aluminum oxide-blasted arom the implant collar to the apex. All Accelx dental implants are intended to be placed 0.5-1.0 mm sub crestal.

    Accelx cover screws are provided with a coronal diameter of 3.5 mm in overall lengths of 5.7 mm, 6.5 mm and gingival heights (cuff heights) of 0.8 mm, 1.6 mm, respectively. The cover screws are manufactured from titanium alloy confirming to ASTM F136 and anodized. The cover screws are single use only. The smallest cover screw is provided sterile within the Subject device implant packaging. They are also provided individually as replacement or alternative parts in the same non-sterile packaging configuration as cleared in K203240.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the Accelx Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and a comparison of technological characteristics. It does not contain information about clinical studies, AI/algorithm performance, multi-reader multi-case (MRMC) studies, or any form of human-in-the-loop performance evaluation.

    Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets those criteria in the context of an AI/ML-driven device, as the submission is for a medical device (dental implant system) that does not incorporate AI/ML.

    However, I can extract the non-clinical acceptance criteria and reported device performance from the document.

    Non-Clinical Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criterion / Test Method (as recommended in FDA guidance)Reported Device Performance
    Modified SurfacesEvaluation by scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS) following media blasting and cleaning."Implant surfaces were evaluated after media blasting and cleaning by scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS) characterization meeting acceptance criteria."
    BiocompatibilityCytotoxicity testing according to ISO 10993-5.
    Bacterial endotoxin testing to ANSI/AAMI ST72, USP and USP .
    Material mediated pyrogenicity per USP Pyrogen Test."Cytotoxicity testing according to ISO 10993-5, bacterial endotoxin to ANSI/AAMI ST72, USP and USP and material mediated pyrogenicity per USP Pyrogen Test was performed on representative devices." (Implies successful completion as per general context of 510(k) submission for substantial equivalence).
    SterilizationGamma sterilization validation for implants according to ISO 13004.
    Moist heat (steam) sterilization for non-sterile cover screws according to ISO 17665-2."Gamma sterilization validation was performed according to ISO 13004 was performed for implants; moist heat (steam) sterilization according to ISO 17665-2 for non-sterile cover screws." (Implies successful validation as per general context of 510(k) submission for substantial equivalence).
    Magnetic Resonance Imaging (MRI) SafetyNon-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795).
    Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque."Non-clinical worst-case MRI review was performed to evaluate the subject device components in the MRI environment using scientific rationale and published literature... rationale addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, including magnetically induced displacement force and torque." (Implies favorable assessment supporting MRI safety, likely "MR Conditional" labeling although not explicitly stated here for all components). The document also states the results demonstrate the device is suitable for intended use.
    Reverse EngineeringTo demonstrate physical compatibility with MegaGen AnyRidge Internal Implant connection. Testing performed on OEM implant bodies, OEM abutments, and OEM abutment screws."Reverse engineering of the MegaGen AnyRidge Internal Implant connection was performed to demonstrate physical compatibility. This testing was performed on OEM implant bodies, OEM abutments, and OEM abutment screws." (Implies successful demonstration of physical compatibility).
    Mechanical PerformanceMechanical performance testing according to ISO 14801:2016, "Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants."
    Worst-case scenario chosen based on FDA guidance document "Root Form Endosseous Dental Implants and Endosseous Dental Implant Abutments.""The fatigue limit data demonstrated that constructs of the previously cleared Accelx abutments (K203240) and previously cleared MegaGen AnyRidge Internal Implant System OEM abutments in combination with Accelx implants have sufficient strength for their intended use."

    Since the device described is not an AI/ML device, the following points are not applicable and thus, the document does not contain information on them:

    1. Sample sizes used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective): No clinical test set data from patients is referenced. The "test set" here refers to the physical units tested in non-clinical lab settings.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, as no ground truth for image interpretation or diagnosis is relevant here. The ground truth for mechanical testing is established by engineering standards and measurements.
    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Ground truth is based on engineering specifications, material science standards (ASTM, ISO), and validated test methods for physical properties.
    7. The sample size for the training set: Not applicable, as there is no AI/ML model for training.
    8. How the ground truth for the training set was established: Not applicable.
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