LogoFDA 510(k) Search
K Number
K052710
Device Name
VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9,
Manufacturer
VIDENT
Date Cleared
2006-01-13

(106 days)

Product Code
EIH
Regulation Number
872.6660
Type
Special
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.

For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.

Device Description

Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental product called "Vita VM®" (porcelain powder for clinical use).

The letter confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It discusses regulatory requirements, classifications, and contact information, but it does not detail any specific performance acceptance criteria or a study conducted to demonstrate the device meets such criteria.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.

§ 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.