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With its "Polywave" broadband spectrum, Bluephase® Style 20i is suitable for the polymerization of all light curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bases, liners, fissure sealants, temporaries, as well as luting materials for brackets and indirect restorations, such as ceramic inlays.

Bluephase® Style 20i is an LED polymerization light that produces energy-rich blue plight. It is used for the polymerization of light-curing dental materials immediately at the dental unit. It consists of 1 Polywave LED in the probe.

• The handpiece has the shape of a pen
  Operational notes: 2 programs (Turbo, High Power)
  Light source: Polywave LED
  Power source: Li-Po battery

The provided text is a 510(k) premarket notification for a medical device called "Bluephase Style 20i," a dental light-curing unit. It does not contain specific details about acceptance criteria, device performance tables, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for an AI/ML-based medical device.

The document primarily focuses on establishing substantial equivalence to a predicate device (Bluephase 20i) based on:

• Indications for Use: Both devices are for polymerization of light-curing dental materials.
• Working Principle: Both use an LED polymerization light to cure dental materials.
• Material Composition: Stated as "No difference."
• Electrical Safety: Both conform to the same IEC standards.
• Biocompatibility: Stated that construction materials are substantially the same as the predicate.
• Software Validation: Mentions full validation and adherence to FDA guidance, but no performance metrics.
• Bench Testing: Confirmed the heat sink switch-off temperature met design specifications.

The document is a regulatory submission for a physical device, not an AI/ML software as a medical device. Therefore, the information requested in your prompt regarding AI/ML device testing (e.g., ground truth, MRMC studies, standalone performance) is not applicable or present in this document.

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For light curing polymerization of light-curing dental materials curing in the wavelength range of 385-515 nm. These materials include restoratives, bonding agents/adhesives, bases, liners, fissure sealants, temporaries, as well as luting mateirals for brackets and indirect restorations, such as ceramic inlays.

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This document is a 510(k) clearance letter from the FDA for a dental curing light, the Bluephase® Style. It approves the device based on substantial equivalence to existing devices. However, this type of document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.

The FDA 510(k) clearance process primarily assesses whether a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that it does not raise different questions of safety and effectiveness and that the data demonstrate that the device is at least as safe and effective as the legally marketed device. This often relies on a comparison to predicate devices rather than requiring extensive new clinical trials with detailed performance metrics and statistical analyses as would be found in a PMA (Premarket Approval) application.

Therefore, I cannot extract the information you requested from this document. The document only confirms the device's clearance and its intended use.

Ask a specific question about this device