(83 days)
Allround E ( Code name: RD1710 ) is a platinum gray color, Copper free, palladium-silver, porcelain-to-metal alloy designed for low fusing porcelain in the market. It is a Noble alloy under Identalloy and ADA classification system for Dental alloy. It can also be used as Type-III crown and bridge alloy. It is suitable for single units, short--span bridge work and long span bridge work. Ideal for combination cases of PTM / PFM and Crowns.
Allround E ( Code name: RD1710 ) is a platinum gray color, Copper free, palladium-silver, porcelain-to-metal alloy designed for low fusing porcelain in the market. It is a Noble alloy under Identalloy and ADA classification system for Dental alloy. It can also be used as Type-III crown and bridge alloy. It is suitable for single units, short--span bridge work and long span bridge work. Ideal for combination cases of PTM / PFM and Crowns.
This document is a 510(k) clearance letter from the FDA for a dental alloy named "Allround-E (Code Name RD 1710)". It does not contain information about acceptance criteria or a study proving that a device meets such criteria.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."
This means the device was cleared based on its substantial equivalence to pre-existing, legally marketed devices, not through a study demonstrating it meets specific performance acceptance criteria.
Therefore, I cannot provide the requested information from the provided text as it is not present in the document.
§ 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.