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K Number
K974089
Device Name
ALLOY PRIMER
Manufacturer
KURARAY AMERICA, INC.
Date Cleared
1997-12-17

(49 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K942917,K970848,K871636
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This device is used for the following indications. All of these intended use are same to those of predicate devices.

  1. Adhesion of metal posts, metal inlays, onlays, crown and bridges.
  2. Repair of fractures resin-based facing crowns and porcelain-fused metal crowns
  3. Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures
Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA regarding a dental product called "Alloy Primer" by Kuraray America, Incorporated. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The letter primarily:

  • Confirms a review of the 510(k) notification.
  • States that the device is substantially equivalent to legally marketed predicate devices.
  • Grants permission to market the device, subject to general controls.
  • Provides information on FDA regulations and resources.

The "Indications For Use" section (Page 2) lists the intended uses of the Alloy Primer and references similar predicate products, but this is not a study report or a performance validation.

Therefore, I cannot extract the requested information about acceptance criteria, device performance, sample sizes, ground truth, or study methodologies from this document.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.