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    K Number
    K232087
    Device Name
    Dental LT Comfort Resin
    Manufacturer
    Formlabs Ohio, Inc.
    Date Cleared
    2024-02-16

    (218 days)

    Product Code
    MQC,CLA,KMY
    Regulation Number
    N/A
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K222061,K183598
    Why did this record match?
    Device Name :

    Dental LT Comfort Resin

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

    Dental LT Comfort Resin when utilized to print dental or orthodontic appliances such as occlusal splints, nightguards, mouthguards and repositioners is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.

    Device Description

    Dental LT Comfort Resin is a light-curable polymer-based resin designed for the fabrication of biocompatible, long-term use, removable dental and orthodontic appliances, such as occlusal splints, nightguards, mouthguards and repositioners by additive manufacturing.

    AI/ML Overview

    The provided text describes the submission and clearance of "Formlabs Dental LT Comfort Resin" by the FDA. It is not an AI/ML medical device submission, it is a statement of substantial equivalence for a new dental resin product to existing predicate devices. Therefore, the information required to answer the questions about acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML medical device is not present in the provided text.

    The document details the following regarding the Dental LT Comfort Resin:

    • Indications for Use: To print dental or orthodontic appliances to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism.
    • Predicate Devices: Dental LT Clear V2 Resin (K222061) and KeySplint Soft (K183598).
    • Technological Characteristics: Light-curable polymer-based resin for additive manufacturing (3D printing) of dental appliances, followed by post-processing (washing, curing, sanding, polishing, disinfecting).
    • Performance Data:
      • Biocompatibility Testing: Evaluated according to ISO 10993-1:2018 and ISO 7405:2018. Results indicated biocompatibility for long-term (>30 days) mucosal membrane contact.
      • Performance Attributes: Tested according to ISO 20795-2, ASTM D 638-14, and ASTM D 2240-15. The results "meet passing criteria or fall between the two predicate devices."

    Key takeaway: The document does not describe an AI/ML algorithm or its performance criteria, but rather the material properties and biocompatibility of a dental resin intended for 3D printing. Therefore, it is impossible to answer the questions about AI/ML device acceptance criteria and study details based on the provided text.

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