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510(k) Data Aggregation

    K Number
    K173020
    Device Name
    OBA-MCP, Orthodontic Bracket Adhesive with MCP
    Manufacturer
    Pulpdent Corporation
    Date Cleared
    2018-01-17

    (111 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K153249,K911286,K880393,K950556
    Why did this record match?
    Device Name :

    OBA-MCP, Orthodontic Bracket Adhesive with MCP

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

    PULPDENT OBA-MCP is a light-cure orthodontic adhesive composite for the direct bonding of orthodontic brackets. For dental professional use only.

    Device Description

    PULPDENT OBA-MCP is a light-cure orthodontic adhesive composite containing modified calcium phosphate that releases fluoride, calcium, and phosphate ions into the oral environment. OBA-MCP is not formulated with Bisphenol A. BisGMA, or BPA derivatives.

    AI/ML Overview

    The provided text is a 510(k) summary for the PULPDENT OBA-MCP (Orthodontic Bracket Adhesive with MCP). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense for an AI/ML medical device.

    Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI/ML device is not available in the provided text.

    The document primarily addresses:

    • Device Description: A light-cure orthodontic adhesive composite containing modified calcium phosphate that releases fluoride, calcium, and phosphate ions.
    • Indications for Use: Light cure orthodontic adhesive composite for the direct and indirect bonding of orthodontic brackets. For dental professional use only.
    • Predicate Device: PULPDENT OBA - Orthodontic Bracket Adhesive (K911286).
    • Reference Device: PULPDENT Solo Flowable Composite with MCP (K153249).
    • Biocompatibility Evaluation: Stated that PULPDENT OBA-MCP is substantially equivalent to the predicate (Pulpdent OBA) which has an established history of safe and effective use. It also mentions that the reference device (Pulpdent Solo Flowable Composite with MCP) was tested with a Cytotoxicity Test (ISO 10993-5 2009) and an Implantation Test (ANSI/ADA Specification 41 and ISO 7405) and found to be biocompatible.
    • Device Comparison: A table comparing the subject device with the predicate and reference devices on aspects like description, technology/mechanism of action, indications for use, composition, and physical properties (appearance, specific gravity, water absorption, fluoride release, phosphate release, calcium release, compressive strength, flexural strength, diametral tensile strength, light cure set times).
    • Discussion of Differences: The key difference is the addition of Modified Calcium Phosphate (MCP) and the removal of BisGMA from the original OBA formulation. The document argues that MCP is biocompatible and that the enamel bond strength of materials with calcium phosphate is comparable to those without it, referencing a study by "Zhang, et.al." (details not provided).

    Since this is a submission for an adhesive material, the "performance" discussed is related to its physical and chemical properties and biocompatibility, not diagnostic or predictive accuracy in the context of AI/ML.

    To directly answer your request based on the provided text, I must state that the information requested for AI/ML device evaluation is not present.

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