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STARBOND SISG: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures.
STARBOND S250: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work and implant over structures.
STARBOND 575P: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as milled work, bars and attachments and cast partial dentures.
STARBOND 650SF: Porcelain to precious metal alloy suitable for single units, short and long span bridges for metal ceramics, as well as implant over structures.
STARBOND 780G: Porcelain to precious metal alloy suitable for a wide range of applications including: single units, short and long span bridges for metal ceramics and milled work and implant over structures.
STARBOND 860G: Porcelain to precious metal alloy surface for Single surface intact inlays, crowns, small and long span bridges as well as crown and bridge frames for metal ceramics
STARBOND 990G: Porcelain to precious metal alloy suitable for low stress situations only, single units with full porcelain coverage.

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This is a 510(k) premarket notification document for several dental bonding alloys (StarBond SISG, S250, S75P, 650SF, 780G, 860G, 990G). The document details the FDA's substantial equivalence determination. However, it does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested.

The document is a regulatory approval letter based on substantial equivalence to predicate devices, not a performance study report for a new device's efficacy or safety. Therefore, the requested information cannot be extracted from the provided text.

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Dental casting Type III alloys intended for manufacturing: Crowns Short Span Bridges Inlays

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental alloy device (Starcast Dental Alloys). It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on:

• Device Name: Starcast Dental Alloys
• Regulation Number: 21 CFR 872.3060
• Regulation Name: Gold-based Alloys and Precious Metal Alloys for Clinical Use
• Regulatory Class: II
• Product Code: EJT
• Indications for Use: Dental casting Type III alloys intended for manufacturing: Crowns, Short Span Bridges, Inlays
• FDA Determination: Substantially equivalent to legally marketed predicate devices.
• General Controls: Requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

To answer your questions, I would need a technical study report, a submission summary, or a similar document describing the actual performance testing of the device.

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