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K Number
K150703
Device Name
CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)
Manufacturer
KURARAY NORITAKE DENTAL INC.
Date Cleared
2015-08-13

(148 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
  • [1] Surface treatment of prosthetic restorations made of ceramic, hybrid ceramics, composite resin or metal
  • [2] Intraoral repairs of fractured restorations made of ceramics, hybrid ceramics, composite resin or metal
Device Description

Not Found

AI/ML Overview

The provided text is a US FDA 510(k) clearance letter for the device "CLEARFIL CERAMIC PRIMER PLUS". This document confirms that the device has been found substantially equivalent to predicate devices. However, this type of document does not contain the information requested in your bullet points regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The FDA 510(k) summary (which is a separate document typically published alongside the clearance letter) or the submission itself would contain details about the performance data. Without access to those documents, I cannot provide the requested information.

The clearance letter focuses on:

  • Confirming substantial equivalence.
  • Listing the device name, regulation number, and product code.
  • Outlining regulatory compliance responsibilities for the manufacturer.
  • Specifying the "Indications for Use" for the device.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for the test set and data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study details.
  6. Standalone performance details.
  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.