LogoFDA 510(k) Search
K Number
K102450
Device Name
IONOLUX PRO
Manufacturer
VOCO GMBH
Date Cleared
2010-10-08

(42 days)

Product Code
EBF
Regulation Number
872.3690
Type
Special
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Ionolux Pro is intended for the following applications:

  1. Restorations class III and V, especially cervical fillings and root caries
  2. Fillings on deciduous teeth
  3. Small class I fillings
  4. Temporary fillings
  5. Core build-up
  6. Lining
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA for a device called "Ionolux Pro," which is a "Tooth Shade Resin Material" used in dentistry. This document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements. It details the indications for use of the device but offers no performance data, study designs, sample sizes, expert qualifications, or ground truth methodologies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.