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K Number
K061322
Device Name
PORCELAIN PRIMER
Manufacturer
J. MORITA USA, INC.
Date Cleared
2006-06-02

(22 days)

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

Porcelain primer is an agent for enhancing bonds to porcelain, ceramic, procured composites and Surfaces of non-precious metals. When prepared with a thin layer of Porcelain Primer, the areas are ready for bonding with acrylic resins. Suitable acrylic resins are bonding resins, flowable composites or composite to for to rooms. Bunaole actylic Testins are oonding resins, flowable work work.

Device Description

Porcelain Primer

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Porcelain Primer." It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information. The document does not describe:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. MRMC comparative effectiveness study results.
  6. Standalone algorithmic performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.