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K Number
K020239
Device Name
TOUCH&BOND-PLUS
Manufacturer
PARKELL, INC.
Date Cleared
2002-03-20

(56 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

This material is indicated for the following:

  1. A dentin bonding agent used with direct filling materials that include but may not be limited to, composite resins, resin modified glass ionomers or compomers, etc.
  2. A dentin bonding agent used with resin cements or composite luting agents to retain indirect tooth-colored and cast alloy restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, laminate veneers, either resin or porcelain, porcelain-fused-to-metal crowns, etc.
  3. Treatment of hypersensitive areas of exposed root surfaces.
  4. A cavity sealant and desensitizer applied to exposed dentin that has been prepared to receive a laboratory fabricated restoration such as porcelain-fused-to-metal crowns, cast alloy or tooth-colored inlays or onlays, veneers, etc.
Device Description

Single bottle, self-etching, self-priming, light-cured bonding system that contains 4-META. Does not require acid etching of tooth surfaces, and can be polymerized with any available light-cure device. For use as the adhesive agent for direct or indirect restorations, and can be used as a sealant/desensitizer to minimize post-operative sensitivity.

AI/ML Overview

This 510(k) premarket notification (K020239) for Parkell, Inc.'s Touch&Bond-Plus device does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

The provided documents are a 510(k) summary and the FDA's clearance letter. These documents primarily focus on:

  • Device identification: Trade name, common name, classification, and predicate devices.
  • Description/Intended Use: What the device is and what it's used for.
  • Substantial Equivalence determination: The FDA's finding that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
  • Regulatory information: Applicable regulations and general controls.

The 510(k) summary (Section {0}) briefly describes the device as a "Single bottle, self-etching, self-priming, light-cured bonding system that contains 4-META" and lists its intended uses. However, it does not include any performance data, acceptance criteria, study methodologies, or results.

Therefore, I cannot populate the table or provide the detailed study information you requested based on the given input. This type of detailed study information is typically found in the full 510(k) submission, not necessarily in the publicly available 510(k) summary or the FDA clearance letter.

§ 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.