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510(k) Data Aggregation
(31 days)
JEL BIOS 10 (CODE NAME RD-1801)
High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the market. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.
High Gold and Platinum containing ceramic alloy for porcelain to metal restorations. It is Palladium, Silver and copper free dental alloy with less than 2.0 % base metal. Jel bios 10 is a rich gold color hard gold base alloy with high yield strength and thermal stability. It is compatible with a wide range of porcelain available in the market. It can be used for porcelain to metal fabrication of single units and all bridge work including single and three or four crowns.
I am sorry, but since the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy, it does not contain information about the acceptance criteria and study details for a device's performance as would be found in a clinical study report. The letter confirms substantial equivalence to a predicate device but does not include the specifics of performance testing.
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