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K Number
K982665
Device Name
JUMBO SILVER-REINFORCED GLASS IONOMER
Manufacturer
CENTRIX, INC.
Date Cleared
1998-09-08

(46 days)

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

Not Found

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Jumbo Silver-Reinforced Glass Ionomer" device does not contain the detailed information necessary to answer your request about acceptance criteria, study design, and performance metrics.

The document is a clearance letter, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory compliance, classification, and permissions to market the device. It does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods.
  • Information about MRMC comparative effectiveness studies, standalone algorithm performance, or the type of ground truth used.
  • Details regarding the training set size or how its ground truth was established.

To obtain this information, you would typically need to refer to the original 510(k) submission document itself, which contains the detailed technical and clinical performance data submitted by the manufacturer to the FDA. Such documents are usually much more extensive than the clearance letter.

§ 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.