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GC Ortho Connect

• 1. Bonding metal brackets and attachments
• 2. Bonding ceramic brackets
• 3. Bonding plastic brackets and acrylic appliances

GC Ortho Etching Gel

• 1. Etching enamel of tooth surfaces
• 2. Enhancing the bond strength of light-cured orthodontic adhesive materials

Not Found

This document is an FDA 510(k) clearance letter for two dental products: GC Ortho Connect and GC Ortho Etching Gel. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the devices are substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from this document.

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Fabricating resin base (understructure) for bracket placement

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device called "GC KommonBase." This letter confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria, study details, or performance data for the GC KommonBase device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than technical performance studies.

Ask a specific question about this device