AUROFLUID CPF

• K Number: K982606
• Device Name: AUROFLUID CPF
• Manufacturer: METALOR DENTAL USA CORP.
• Date Cleared: 1998-10-15 ( 80 days)
• Product Code: EJT
• Regulation Number: 872.3060
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For Use in the Fabrication of Dental Crowns, Bridges, Inlays and Onlays.

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 product called "Aurofluid CPF". This document primarily focuses on regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the given text.

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.