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K Number
K014027
Device Name
OPTIBOND SOLO PLUS 4
Manufacturer
KERR DENTAL MATERIALS CENTER
Date Cleared
2002-02-22

(78 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

Optibond Solo Plus 4 is a self-etch primer designed to work in conjunction with a tooth bonding agent. Optibond Solo Plus 4 can be used for indirect situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, post and core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns and bridges (used in conjunction with a resin luting agent).

Device Description

OptiBond Solo Plus 4 self-etch primer is designed for use with OptiBond Solo Plus adhesive (in Unidose or bottle delivery), both a Class II device which were granted marketing clearance by FDA following the submission of a 510(k) premarket notification. When used with OptiBond Solo Plus or OptiBond Solo Plus with Activator, the self etch primer can be used in the bonding of both direct and indirect restorations. The self-etch primer is used to eliminate the phosphoric acid etch step in the bonding process. Some advantages of using a self etch primer include reduction of post-operative sensitivity and an elimination of steps in the bonding process.

AI/ML Overview

This document is a 510(k) summary for a dental adhesive product, Optibond Solo Plus 4. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study demonstrating acceptance criteria for its performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be fully provided from the given text. The document does not describe specific performance acceptance criteria for the bonding agent, nor does it detail a study designed to test against such criteria.

Here's what can be inferred or stated based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

  • Acceptance Criteria: Not explicitly stated in the document. The document's purpose is to demonstrate substantial equivalence, not to define or meet specific performance criteria beyond what is implied by the predicate device's performance.
  • Reported Device Performance: Not detailed in terms of specific quantitative outcomes of a performance study. The document broadly states that the device "functions in a manner similar" to predicate devices, implying comparable performance without providing the metrics.

2. Sample Size Used for the Test Set and Data Provenance:

  • Sample Size for Test Set: Not mentioned. No specific "test set" in the context of a performance study is described.
  • Data Provenance: Not mentioned. No performance data from clinical or laboratory studies is presented in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

  • Number of Experts: Not applicable. Given there's no performance study data presented, there's no mention of experts establishing ground truth for such a study.
  • Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

  • Adjudication Method: Not applicable. No test set or ground truth establishment process is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

  • MRMC Study: No. This type of study (common in imaging AI) is not relevant to a dental bonding agent and is not mentioned or implied in the document.
  • Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study:

  • Standalone Study: No. This concept is not applicable to a physical dental bonding agent product.

7. Type of Ground Truth Used:

  • Type of Ground Truth: Not applicable. As no performance study with ground truth is described, this information is not available.

8. Sample Size for the Training Set:

  • Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm or a "training set."

9. How the Ground Truth for the Training Set Was Established:

  • Ground Truth Establishment for Training Set: Not applicable.

Summary of what the document does provide:

  • Device Name: Optibond Solo Plus 4
  • Intended Use: Direct situations (composite to enamel/dentin, repair, amalgam sealing, post and core build-up) and indirect situations (veneers, onlays, inlays, crowns, bridges with resin luting agent).
  • Predicate Devices: Kuraray America, Inc., Clearfil Liner Bond 2V.
  • Claim of Substantial Equivalence: The document asserts that Optibond Solo Plus 4 is substantially equivalent to other legally marketed devices, including the predicate, and "functions in a manner similar to" these. This is the primary "proof" offered for regulatory clearance, not a detailed performance study against specific criteria.

§ 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.