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K Number
K130421
Device Name
MERON APPLICATION CAPSULES
Manufacturer
VOCO GMBH
Date Cleared
2013-08-14

(175 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
  • Luting of metal-based crowns, bridges, inlays and onlays
  • Luting of high-strength all-ceramic crowns and bridges (such as aluminum oxide, lithium di silicate and zirconium oxide ceramics)
  • Luting of metal-based and high-strength all-ceramic crowns and bridges (such as aluminum oxide, lithium disilicate and zirconium oxide ceramics) on implant abutments
  • Luting of metal root posts or indirect metal post core build-ups
  • Luting of prefabricated steel crowns
  • Luting of orthodontic bands
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification and does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA letter confirming the substantial equivalence of MOCO GmbH's Meron Application Capsules to a legally marketed predicate device, along with the device's indications for use.

It does not include details on:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.