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K Number
K090817
Device Name
IONOLUX
Manufacturer
VOCO GMBH
Date Cleared
2009-07-23

(120 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
K961584
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

lonolux 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

Ionolux is a resin-reinforced radiopaque light-curing glass-polyalkenoate restorative. The material has outstanding aesthetics, good handling properties and high chemical adhesion.

AI/ML Overview

This document describes a 510(k) premarket notification for a dental cement called Ionolux. As such, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

510(k) summaries are primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing comprehensive study results against specific performance criteria. The provided text indicates that:

  • Technological characteristics: "All of the components of Ionolux are found in the legally marketed device GC Fuji II LC improved (K961584, GC America, Inc.)"
  • Safety and effectiveness: "The prior use of all of the components of Ionolux in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional blocompatibility studies with the final formulation are not necessary. We believe that the prio use of the components of lonolux in legally marketed devices and the performance data and results provided support the safety and effectiveness of lonolux for the intended use."

This essentially states that the device is considered safe and effective because its components are already used in a legally marketed predicate device, and therefore, extensive new testing (like a standalone performance study with detailed acceptance criteria) was deemed unnecessary for this 510(k) submission.

Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval through substantial equivalence, not on a detailed performance study with explicit acceptance criteria.

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.