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K Number
K102341
Device Name
VIPI BLOCK
Manufacturer
VIPI INDUSTRIA,COMERCIO,EXPORTACAO E IMPORTACAO DE
Date Cleared
2010-12-16

(120 days)

Product Code
EBG
Regulation Number
872.3770
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The VIPI Block is a PMMA blank for manufacturing temporary crowns and bridges by a CAD/CAM system.

Device Description

The VIPI Block is a PMMA blank for manufacturing temporary crowns and bridges by a CAD/CAM system.

AI/ML Overview

This looks like a 510(k) clearance letter for a dental device, specifically a PMMA blank for manufacturing temporary crowns and bridges. This document does not contain the type of information requested about acceptance criteria and study details for an AI/ML powered medical device.

The document confirms that the device, VIPI Block, is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It does not include:

  • A table of acceptance criteria and reported device performance.
  • Details about test set sample size, provenance, or ground truth establishment.
  • Information on expert validation, adjudication methods, or MRMC studies.
  • Any mention of AI or machine learning algorithms.

Therefore, I cannot fulfill your request using the provided text.

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.