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K Number
K021038
Device Name
GC ELITE CEMENT 100
Manufacturer
GC AMERICA, INC.
Date Cleared
2002-05-03

(32 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

GC Elite Cement 100 is a zinc phosphate cement used for cementation of crowns, bridges and inlays.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter for a dental cement (GC Elite Cement 100). It establishes substantial equivalence to a predicate device, allowing it to be marketed.

However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to a medical device's performance in terms of diagnostic accuracy or clinical outcomes.

The letter from the FDA primarily addresses regulatory aspects, classification, and general controls for the device. It indicates that the device is a "Dental Cement" and provides its "Indications For Use" which is for "cementation of crowns, bridges and inlays."

Therefore, I cannot provide the requested information from the given text as it does not describe device performance criteria, a study, or any of the detailed aspects about clinical performance evaluation that your request asks for (e.g., sample size, data provenance, expert qualifications, ground truth, MRMC study, standalone performance, training set details).

§ 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.