CEREC VITABLOCKS MK2

• K Number: K022408
• Device Name: CEREC VITABLOCKS MK2
• Manufacturer: B.B.'S PROPHY SHOP
• Date Cleared: 2002-09-06 ( 44 days)
• Product Code: EIH
• Regulation Number: 872.6660
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

Production of ceramic inlays, onlays, veneers, crowns & bridges using the Cerec machine

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a dental device called "VITABLOCS® Mark II," identified by the 510(k) number K022408. This document does not contain information about acceptance criteria, device performance studies, or details relevant to AI/ML device evaluations.

Specifically, it is a notification of substantial equivalence for a porcelain powder for clinical use (ceramic blocks for dental restorations). The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) from this document. This kind of information is typically found in a comprehensive premarket notification (510(k)) submission, not in the FDA's clearance letter itself.

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.