(48 days)
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.
Not Found
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.
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.