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510(k) Data Aggregation

    K Number
    K192806
    Device Name
    DENTCA Crown and Bridge
    Manufacturer
    Dentca, Inc.
    Date Cleared
    2020-02-05

    (127 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DENTCA Crown and Bridge

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

    DENTCA Crown and Bridge is a light-curable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges.

    The fabrication of temporary crowns or bridges with DENTCA Crown and Bridge requires digital models of crowns or bridges, a stereolithographic additive printer, and curing light equipment.

    Device Description

    DENTCA Crown and Bridge is a light-curable resin to fabricate, by additive manufacturing, temporary crowns or bridges.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental device called "DENTCA Crown and Bridge." These documents typically focus on demonstrating substantial equivalence to a predicate device based on performance characteristics and indications for use, rather than detailed studies with acceptance criteria, sample sizes, and ground truth methodologies akin to what you'd find for AI/ML-based diagnostic devices.

    Therefore, the specific information requested in your prompt (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not available in the provided text because it's not relevant to a 510(k) clearance for this type of device.

    This document describes a light-curable resin used to fabricate temporary crowns or bridges via additive manufacturing. The clearance is based on demonstrating that this new material performs comparably to existing, legally marketed temporary crown and bridge resins. The "study" here would typically involve material property testing (e.g., mechanical strength, water absorption, biocompatibility) rather than clinical studies with human readers, AI algorithms, or pathology ground truth.

    If this were an AI/ML-driven diagnostic device submission, the FDA would require extensive detail on the performance evaluation as outlined in your prompt. However, for a dental resin, the focus is on material properties and how those properties compare to predicate devices.

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