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K Number
K061535
Device Name
GC XLC-100 CAPSULE
Manufacturer
GC AMERICA, INC.
Date Cleared
2006-07-14

(42 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 XLC-100 is a radiopaque, dual-curing, self-adhesive resin cement in capsulated form for cementing metal, porcelain fused to metal, resin and ceramic restorations.

Device Description

GC XLC-100 is a radiopaque, dual-curing, self-adhesive resin cement in capsulated form.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental cement product, not a study report for an AI/ML medical device. Therefore, it does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.

The document discusses:

  • The trade/device name: GC XLC-100 Capsule
  • Regulation Number: 21 CFR 872.3275(b)
  • Regulation Name: Dental Cement
  • Regulatory Class: II
  • The FDA's determination of substantial equivalence to a legally marketed predicate device.
  • Indications for Use: "GC XLC-100 is a radiopaque, dual-curing, self-adhesive resin cement in capsulated form for cementing metal, porcelain fused to metal, resin and ceramic restorations."

None of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is present in this regulatory letter as it pertains to a traditional medical device, not an AI/ML product.

§ 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.