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K Number
K140993
Device Name
IONOSTAR MOLAR
Manufacturer
VOCO GMBH
Date Cleared
2014-10-20

(186 days)

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

lonoStar Molar is intended for use as:

  • Restorations of non occlusion-bearing class I cavities
  • Semi-permanent restorations of class I and II cavities
  • Restorations of cervical lesions, class V cavities, root caries
  • Restorations of class III cavities
  • Restoration of deciduous teeth
  • Base/liner
  • Core build-up
  • Temporary restorations
Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a dental cement called "IonoStar Molar." It is not a study report or clinical trial document that details acceptance criteria and device performance in the context of an AI-powered medical device. Therefore, I cannot extract the requested information regarding:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes and data provenance for a test set.
  • Number and qualifications of experts for ground truth.
  • Adjudication method for the test set.
  • MRMC comparative effectiveness study results.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Training set sample size and ground truth establishment.

The document discusses the regulatory classification (Class II), product code (EMA), and indications for use for a dental cement. It focuses on the substantial equivalence determination to a predicate device, which is a regulatory pathway for certain medical devices, rather than a detailed performance study for an AI algorithm.

§ 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.