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K Number
K141503
Device Name
DENALI 501CEMENT
Manufacturer
DENALI CORPORATION
Date Cleared
2014-11-10

(157 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
K132393,K971372,K053565
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. For Use only by a Licensed Dentist. Rx Use Only.

Device Description

Denali 501 Cement is a two part, resin-based cement recommended for the bonding of ceramic, metal and composite restorations. Denali 501 contains polymerizable monomers that can set in either a light activated mode or set upon mixing Part A and Part B. When set the resin has a low solubility in water to act as a long term cement.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification summary from the FDA for a dental cement called "Denali 501 Cement." It discusses the device's substantial equivalence to predicate devices based on various characteristics, but it does not detail specific acceptance criteria or a study designed to evaluate them in the context of your request.

Therefore, I cannot provide the requested table or the details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

§ 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.