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510(k) Data Aggregation

    K Number
    K230797
    Device Name
    SmartMTA Capsule
    Manufacturer
    Sprig Oral Health Technologies, Inc.
    Date Cleared
    2023-03-24

    (2 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K132825
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SmartMTA Capsule is indicated for use as:

    • Orthograde root canal filling material
    • Repair of root perforations during root canal therapy (endodontic therapy), or as a consequence of internal and external resorption.
    • Repair of root canals as an apical plug during apexification
    • Root end filling
    • Pulp capping
    • Pulpotomy/Partial Pulpotomy
    Device Description

    The major compositions of the SmartMTA Capsule are Calcium Carbonate (CaCO3), Silicon Dioxide (SiO₂), Aluminum Oxide (Al₂O₃), Zirconium Oxide (ZrO₂) and Distilled water and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water and is used in a putty form which gradually hardens in the oral environment. SmartMTA Capsule is ideal for orthograde root canal filling. SmartMTA Capsule is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not mentioned.

    Device Name: SmartMTA Capsule
    Predicate Device: RetroMTA-OrthoMTA II (K132825)

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present "acceptance criteria" for the device in the typical sense of a target performance threshold that must be met. Instead, it compares the SmartMTA Capsule's performance to the predicate device and relevant ISO standards, explaining deviations. The key performance metrics and their reported values are derived from the ISO 6876:2012 standard testing where applicable.

    Test / Performance MetricAcceptance Criteria (from ISO 6876:2012)Candidate Device (SmartMTA Capsule) Performance (200/140 ratio)Candidate Device (SmartMTA Capsule) Performance (200/160 ratio)Predicate Device (RetroMTA) PerformanceNotes on Acceptance / Deviations
    Flow> 17mm9.375 mmNot explicitly stated if it met > 17mm, but implied to be in the "established range"Not testedCandidate device (200/140 ratio) did not meet criteria, but explained as not critical due to intended use and hydrophilic nature. 200/160 ratio did fall in range.
    Working Time≤ 30 minNot tested20 minutesNot testedCandidate device (200/140 ratio) not tested/measurable according to standard. 200/160 appeared to meet the criteria. Explained as not critical due to intended use and hydrophilic nature, and dependency on water-to-cement ratio.
    Setting Time3.5 hours ± 10% (3h30min ± 10%)60 minutes3h35 minutes2.5 minutes to 27 minutesCandidate device (200/140 ratio) setting time of 60 minutes is significantly faster than 3.5 hours ± 10%. Candidate device (200/160 ratio) setting time of 3h35 minutes meets the criteria. Predicate showed a wide range, some much faster than the standard.
    Film Thickness≤ 50μmNot tested43μmNot testedCandidate device (200/140 ratio) not tested/measurable according to standard. 200/160 ratio met the criteria. Explained as not critical due to intended use.
    Solubility
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