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K Number
K120283
Device Name
DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT
Manufacturer
NOVOCOL, INC.
Date Cleared
2012-07-31

(182 days)

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

"Dimer Dual Cure Temporary Resin Cement" is indicated for the temporary cementation of provisional restorations such as crowns and Bridges, inlays and onlays, Maryland bridges, veneers or for the temporary cementation of permanent dental restorations.

"Dimer Dual Cure Permanent Resin Cement" is indicated for the final cementation of implant prostheses, crowns and bridges, inlays and onlays, Maryland bridges, veneers, pins and posts and also periodontal splinting.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a dental cement. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

The document primarily focuses on:

  • Acknowledging the 510(k) submission for "Dimer Dual Cure Permanent Resin Cement" and "Dimer Dual Cure Temporary Resin Cement."
  • Stating that the device is substantially equivalent to legally marketed predicate devices.
  • Outlining the general controls and regulations applicable to the device.
  • Providing the Indications for Use for both permanent and temporary resin cements.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study from this document, as that information is not present.

§ 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.