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GC Fuji ORTHO BAND PASTE PAK is intended to be used for cementation of orthodontic bands. It is also used for the cementation of appliances retained with stainless steel crowns. I.e. Herbst or expansion appliances.

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This is a 510(k) premarket notification for a dental adhesive, GC Fuji ORTHO BAND PASTE PAK. The provided text is a formal FDA letter confirming a substantial equivalence determination and does not contain information about acceptance criteria, device performance, study details, or AI-related metrics. It primarily focuses on regulatory compliance and the ability to market the device.

Therefore, I cannot extract the requested information from the provided input. The questions in your prompt are typically relevant for AI/ML device submissions, which involve performance evaluation against specific metrics. This document is for a traditional medical device (dental cement) where "acceptance criteria" are generally established through established ASTM or ISO standards for material properties, not through clinical study metrics like sensitivity, specificity, or human-in-the-loop performance.

If you have a different document (e.g., the actual 510(k) submission or a clinical study report for an AI/ML device), I would be happy to analyze it for the requested information.

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GC Fuji Ortho LC is a glass ionomer dental cement designed for use as an orthodontic adhesive for brackets, bands and bonded appliances.

GC Fuji Ortho LC is a glass ionomer dental cement.

This document is an FDA 510(k) clearance letter for a dental cement. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria as typically found in a performance study report for an AI/ML device. Therefore, I cannot extract the requested information from this document.

Ask a specific question about this device

Ask a specific question about this device