(34 days)
K#002863
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No
The summary describes a dental composite material, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts like image processing or performance metrics associated with algorithmic analysis.
No
The device is a dental restorative material, not a therapeutic device. It is used to fill cavities and repair dental materials, which are structural and aesthetic functions rather than treating disease or alleviating symptoms in a therapeutic sense.
No
Explanation: The device is a resin material used for dental restorations and repairs, not for diagnosing conditions.
No
The device description clearly states it is a "low viscous, light cured hybrid composite dental tooth shade resin material," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "dental tooth shade resin material" for use in "various dental procedures" like restorations and repairs. This involves working directly on the tooth within the patient's mouth.
- Device Description: The description reinforces that it's a "low viscous, light cured hybrid composite dental tooth shade resin material."
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body) to diagnose a condition, monitor a disease, or screen for a disease. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
Therefore, ESTELITE FLOW QUICK is a dental restorative material used in vivo (within the body), not an IVD.
N/A
Intended Use / Indications for Use
ESTELITE FLOW QUICK is a low viscous, light cured hybrid composite dental tooth shade resin material. It is intended for use in various dental procedures, including direct anterior and posterior restorations (particularly for small/shallow/tunnel shaped cavities), as the first layer of direct restorations, blocking out cavity undercuts before fabricating indirect restorations, and repair of porcelain/composite materials.
Product codes
EBF
Device Description
ESTELITE FLOW QUICK is a low viscous, light cured hybrid composite dental tooth shade resin material.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
K#002863
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
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