PORS ON LITE

• K Number: K972910
• Device Name: PORS ON LITE
• Manufacturer: DEGUSSA CORP.
• Date Cleared: 1997-10-14 ( 68 days)
• Product Code: EJT
• Regulation Number: 872.3060
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Device Alloy: Porcelain Fused To Metal Crowns -Full Metal Crowns - Bridges of any span length

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy, specifically "PORS ON LITE". This document does not contain information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) devices.

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Regulation Number and Section

§ 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.