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K Number
K022300
Device Name
ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V
Manufacturer
DENTAL VIPI LTDA
Date Cleared
2002-10-03

(79 days)

Product Code
ELM
Regulation Number
872.3590
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H. and Vipi Dent V Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.

Device Description

Not Found

AI/ML Overview

This document is a FDA 510(k) premarket notification letter for "Preformed Plastic Denture Teeth." It confirms that the devices are substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance results, study designs, sample sizes, ground truth establishment, or expert qualifications. The letter is a regulatory approval, not a study report. Therefore, I cannot extract the requested information.

§ 872.3590 Preformed plastic denture tooth.

(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.