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K Number
K060441
Device Name
VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98
Manufacturer
VIDENT
Date Cleared
2006-04-27

(65 days)

Product Code
EIH
Regulation Number
872.6660
Type
Traditional
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.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental device called "Vita VM® Porcelain Powder for Clinical Use." It grants clearance based on substantial equivalence to a predicate device.

Crucially, this document does NOT contain information about acceptance criteria, a specific study proving the device meets those criteria, or any details related to sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter is a regulatory approval document and focuses on:

  • Device Identification: Trade Name, Regulation Number, Regulation Name, Product Code.
  • Regulatory Classification: Class II.
  • Substantial Equivalence: The FDA has determined the device is substantially equivalent to a legally marketed predicate device.
  • Conditions of Marketing: Subject to general controls (registration, listing, GMP, labeling) and potentially additional controls for Class II devices.
  • Indications for Use: Vita VM® porcelains are indicated as a veneering material for fixed prostheses (crowns, bridges, dental implant abutments)
  • User: By or on the order of a dental professional (DDS or DMD).

Therefore, I cannot provide the requested information based solely on the provided text. The information requested typically comes from a detailed "510(k) Summary" or the full "510(k) Premarket Notification" submission itself, which would include performance data and testing details. This letter is the FDA's response to that submission, not the submission itself.

§ 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.