STABILOR HN

• K Number: K973288
• Device Name: STABILOR HN
• Manufacturer: DEGUSSA CORP.
• Date Cleared: 1997-11-19 ( 78 days)
• Product Code: EJS
• Regulation Number: 872.3060
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

DENTAL ALLOY BRIDGE WORK OF ANY LENGTH FULL METAL CROWN

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental alloy named "Stabilor HN". It does not contain any information about acceptance criteria or a study proving device performance. This letter is simply an approval to market the device based on its substantial equivalence to previously marketed devices.

Therefore, I cannot provide the requested information as it is not present in the provided document.

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.