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K Number
K012436
Device Name
MODIFICATION TO ALLOY PRIMER
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2001-09-04

(35 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K974089
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Statement of the intended use

ALLOY PRIMER is indicated for the following applications:

  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

ALLOY PRIMER is an adhesion primer between dental metal alloy and resin-based material for dental practitioner or dental technician, and comprises methacrylate monomers and solvent. It is used a kind of bonding agent between metal and/or tooth substrate using resin-based materials for the intended uses.

AI/ML Overview

The provided document is a 510(k) summary for the device ALLOY PRIMER by Kuraray Medical Inc. It primarily focuses on changing the manufacturer's name and address and states that the device is "essentially the same" as a previously cleared predicate device (K974089).

Therefore, the document does not contain information about new acceptance criteria or a study proving the device meets new acceptance criteria. It refers to the predicate device having already satisfied these requirements.

Based on the provided text, I cannot fill in the requested table and study details because the submission is for an administrative change and not for a new device requiring a new performance study.

However, I can extract information related to what typically would be expected if such a study were present:

Missing Information:

  • Acceptance Criteria and Reported Device Performance: This document does not establish new acceptance criteria or report new device performance data. It relies on the predicate device's performance.
  • Sample size used for the test set and the data provenance: Not applicable, as no new test set was used for a new study.
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  • Adjudication method for the test set: Not applicable.
  • Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
  • Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable.
  • Type of ground truth used: Not applicable.
  • Sample size for the training set: Not applicable.
  • How the ground truth for the training set was established: Not applicable.

What the document does state:

  • Device Name: ALLOY PRIMER
  • Predicate Device: ALLOY PRIMER by Kuraray Co., Ltd. (K974089)
  • Reason for 510(k) submission: "to alter the name and address of manufacturer, and not to intend other changes."
  • Technological Characteristics and Safety: "This device is essentially the same as ALLOY PRIMER manufactured by Kuraray Co., Ltd. Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as ALLOY PRIMER (K974089)."
  • Intended Use: "The intended uses of this device are... completely the same as ALLOY PRIMER manufactured by Kuraray Co., Ltd. (K974089)."
    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.
  • Classification Name: Resin tooth bonding agent (21CFR 872.3200)
  • Regulatory Class: II
  • Product Code: KLE

Conclusion:

This 510(k) submission is for a change in manufacturer information, asserting substantial equivalence to a previously cleared device. It does not present new acceptance criteria or a study demonstrating the device meets such criteria because it claims the device is identical in all relevant aspects to its predicate. Therefore, the detailed information about studies and acceptance criteria is inherent to the predicate device's clearance (K974089) and not present in 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.