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510(k) Data Aggregation

    K Number
    K190043
    Device Name
    Halley resin
    Manufacturer
    Dentsply Sirona
    Date Cleared
    2019-04-24

    (105 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K161330,K162572
    Why did this record match?
    Reference Devices :

    K161330

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

    Halley resin is a light-cured resin indication of dentures bases in dental laboratories, including full and partial dentures as well as implant overdentures, and other dental appliances. Halley resin can be used as a try-in material for evaluation prior to fabrication of the final restoration of these prostheses require a computer-aided design and manufacturing (CAD/CAM) system using an additive printer.

    Halley resin can be utilized as an aid in bonding denture teeth as well as repair using traditional techniques.

    Device Description

    The proposed Halley resin is a methacrylate-based, light-cured resin available in multiple shades and is intended as an alternative to traditional heat cured and autopolymerization denture base resins. The Halley resin is intended to be utilized primarily for the fabrication of dental prostheses using an additive printer and CAD/CAM techniques. The proposed Halley resin can also be used for traditional repairs and as an aid in bonding denture base to denture teeth.

    In addition, Halley resin may also be utilized as an aid in bonding the printed denture to teeth as well as for repair.

    AI/ML Overview

    The document describes the acceptance criteria and study proving the device meets them for the "Halley resin."

    1. Table of Acceptance Criteria and Reported Device Performance:

    Physical PropertyStandard (ISO) Specification Limit (Type 4)Standard (ISO) Specification Limit (Type 2)Proposed Device Halley resin (Type 4) Reported PerformancePredicate Device NextDent™ Denture / E-Denture (K162572) (Type 4) Reported Performance*Reference Device Pour Acrylic (K161330) (Type 2) Reported Performance**
    Ultimate Flexural Strength (MPa)65 MPa min.60 MPa min.Meets ISO 20795-1:2013 for Type 4 materialMeets ISO 20795-1:2013 for Type 4 material (>65 MPa)Meets ISO 20795-1:2013 for Type 2 material
    Flexural Modulus (MPa)2000 MPa min.1500 MPa min.Meets ISO 20795-1:2013 for Type 4 materialMeets ISO 20795-1:2013 for Type 4 material (>2000 MPa)Meets ISO 20795-1:2013 for Type 2 material
    Water Sorption (µg/mm³)32 µg/mm³ max.32 µg/mm³ max.Meets ISO 20795-1:2013 for Type 4 materialMeets ISO 20795-1:2013 for Type 4 material (≤ 32 µg/mm³)Meets ISO 20795-1:2013 for Type 2 material
    Water Solubility (µg/mm³)1.6 µg/mm³ max.8.0 µg/mm³ max.Meets ISO 20795-1:2013 for Type 4 materialExceeds ISO 20795-1:2013 for Type 4 material (
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