HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM

• K Number: K034049
• Device Name: HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM
• Manufacturer: HERAEUS KULZER GMBH
• Date Cleared: 2004-03-01 ( 62 days)
• Product Code: EJT
• Regulation Number: 872.3060
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Reconstruction of porcelain to metal dental restorations/reconstruction of dental restorations.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer GmbH & Company KG, confirming that their dental alloys are substantially equivalent to legally marketed predicate devices for the indicated uses. It outlines regulatory requirements and allows the company to market their devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or details about the training set.

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.