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K Number
K102612
Device Name
VOCO IONOFIL MOLAR AC QUICK
Manufacturer
VOCO GMBH
Date Cleared
2010-11-19

(70 days)

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

VOCO lonofil Molar AC Quick is intended for the following applications:

  • restoration of V-shaped defects and cervical enamel or root erosions including class V cavities
  • restoration of deciduous teeth (especially class I)
  • fillings of class II cavities (non-occlusion-bearing) by means of tunnel preparations
  • build-up fillings and linings, core build-up
  • temporary long-term treatment of class I and II cavities
Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a dental cement product, "VOCO Ionofil Molar AC Quick." This type of document primarily confirms that a new device is substantially equivalent to a legally marketed predicate device, and it outlines regulatory obligations.

It does NOT contain information about specific acceptance criteria for device performance, nor does it describe clinical studies proving a device meets such criteria.

Therefore, I cannot provide the requested information based on this document. The document's purpose is regulatory clearance, not the presentation of performance study results.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or a detailed technical submission for the device.

§ 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.