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K Number
K132393
Device Name
CERCOM II CEMENT
Manufacturer
DENALI CORPORATION
Date Cleared
2014-03-14

(225 days)

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

CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations.

Device Description

CERCOM II Cement is a self-adhesive cement recommended for the bonding of ceramic, metal and composite restorations. CERCOM II has the same technological characteristics (intended use, application mechanism) as the predicate device CERCOM, except that CERCOM II is a dual-cure cement. CERCOM II can set on its own as well as set with visible light cure.

AI/ML Overview

This looks like a regulatory approval document (510(k) Summary) for a dental cement, not a study describing the performance of a medical device against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.

The document states that the CERCOM II Cement is "substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate cement products cited." This means it was approved based on its similarity to previously cleared devices, rather than a new standalone clinical trial with specific performance metrics and acceptance criteria.

To answer your request, I would need a document specifically detailing a performance study for a device, including its acceptance criteria and the results of that study.

§ 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.