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K Number
K012734
Device Name
CLEARFIL NEW BOND
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2001-09-14

(31 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K943167
Predicate For
K131430
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CLEAFIL NEW BOND is indicated for the following applications:

  1. A dentin and enamel bonding system for composite resin restoration
  2. A dentin and enamel bonding system for amalgam restoration
Device Description

CLEARFIL NEW BOND is classified into Resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling. Normally composite resins and amalgams are used as filling material for this purpose.

AI/ML Overview

The provided text is a 510(k) summary for a dental adhesive system called CLEARFIL NEW BOND. It describes the device, its intended use, and states that it is essentially the same as a previously cleared predicate device (K943167).

However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a submission to the FDA seeking clearance based on substantial equivalence to an existing device, not a report of performance testing against specific criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

  1. A table of acceptance criteria and the reported device performance: Not present.
  2. Sample size used for the test set and the data provenance: Not present, as no performance test is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method for the test set: Not present.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
  6. If a standalone performance study was done: Not present.
  7. The type of ground truth used: Not present.
  8. The sample size for the training set: Not present, as this is not an AI/algorithm-based device and no training set is mentioned.
  9. How the ground truth for the training set was established: Not present.

The document focuses on:

  • Identifying the submitter and device.
  • Classifying the device.
  • Stating its equivalence to a predicate device (K943167).
  • Describing its intended use (dental bonding agent).
  • Asserting that its technological characteristics, chemical ingredients, and safety are "completely the same" as the predicate device.

The FDA's letter (pages 2-3) confirms their review of the submission and their determination of "substantial equivalence" to legally marketed predicate devices. This substantial equivalence determination is the basis for clearance, rather than a new performance study to meet specific acceptance criteria for a novel device.

§ 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.