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K Number
K033938
Device Name
CLEARFIL PROTECT BOND
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2004-01-29

(41 days)

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

The CLEARFIL PROTECT BOND device is indicated for the following applications:

  1. direct restorations using light-cured composite resin or compomer
  2. cavity sealing as a pretreatment for indirect restorations
  3. treatment of hypersensitive and/or exposed root surfaces
  4. intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics, or composite resin using light-cured composite resin
  5. surface treatment of prosthetic appliances made of porcelain, hybrid ceramics, or cured composite resin
  6. core build-ups using light- or dual-cured composite resin
  7. cavity sealing under amalgam restorations
    For indications 1, 2, 3, 6, and 7 the device exhibits an antibacterial cavity cleansing effect.
Device Description

CLEARFIL PROTECT BOND is a resin-based dental adhesive system. The device includes the antibacterial ingredient, 12-methacryloyloxydodecylpyridinium bromide (MDPB).

AI/ML Overview

The provided text is a 510(k) summary for a dental adhesive system, CLEARFIL PROTECT BOND, and a letter from the FDA. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. Therefore, I cannot generate the requested table and study details.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and adding an "antibacterial cavity cleansing effect" claim. It mentions "substantial safety and efficacy testing" and "biocompatibility studies" and "efficacy studies," but it does not provide any specifics about these studies, their design, acceptance criteria, sample sizes, or ground truth establishment.

In summary, the input text does not contain the information required to answer your request.

§ 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.