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• [1] Direct restorations using light-cured composite resin
• [2] Sealing of a prepared cavity or abutment tooth as a pretreatment for indirect restorations
• [3] Treatment of exposed root surfaces
• [4] Treatment of hypersensitive teeth
• [5] Intraoral repairs of fractured restorations
• [6] Post cementation and core build-ups
• [7] Cementation of indirect restorations

CLEARFIL Universal Bond Quick 2 consists of BOND and K-ETCHANT Syringe. BOND is a light-cure bonding agent that allows for the treatment of dentin, enamel, and prosthetic materials. Depending on the indication, BOND is used as self-etching or with K-ETCHANT Syringe for selective enamel etching or total-etching procedures. BOND is intended to be used for both direct and indirect restorations. CLEARFIL DC Activator activates the dual-curing mechanism of BOND; however, the addition of CLEARFIL DC Activator to the adhesive is not required when using BOND with CLEARFIL DC CORE PLUS, self-adhesive resin cements manufactured by Kuraray Noritake Dental Inc. (Kuraray's self-adhesive cements, e.g. PANAVIA SA Cement Universal) or PANAVIA Veneer LC. K-ETCHANT Syringe is an etching gel that consists of 35 % phosphoric acid aqueous solution and colloidal silica.

This document is a 510(k) Premarket Notification from the FDA regarding a dental bonding agent, CLEARFIL Universal Bond Quick 2. It details the device's indications for use, its substantial equivalence to predicate devices, and the testing performed to demonstrate this equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria Table and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not explicitly state the sample sizes used for the shear/tensile bond strength or fluoride release testing. It states that "certain tests were performed on this device, in comparison with the primary predicate device..." and references "the results of comparative study."

Regarding data provenance: The applicant, Kuraray Noritake Dental Inc., is based in Japan (1621 Sakazu, Kurashiki, Okayama 710-0801, Japan). The testing appears to be in-house testing performed by the manufacturer to demonstrate substantial equivalence, rather than a large-scale clinical trial with specific regional data. The document mentions "in-house standard" for compliance. The data is retrospective in the sense that it represents a snapshot of the device's performance at the time of submission.

3. Number of Experts and Qualifications:

The document does not mention the use of experts to establish ground truth for a test set. This type of submission relies on physical and chemical performance testing against defined quantitative criteria (e.g., bond strength in MPa). There were no human studies (e.g., diagnostic studies) mentioned that would require expert adjudication.

4. Adjudication Method:

Not applicable. As described above, this submission focuses on objective laboratory performance metrics, not human-read subjective assessments that would require adjudication.

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

No MRMC study was conducted or mentioned. This is a dental bonding agent, not an AI-assisted diagnostic tool. Therefore, there's no concept of human readers improving with AI assistance.

6. Standalone Algorithm Performance:

Not applicable. This is a physical and chemical product, not a software algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance evaluation is based on pre-defined quantitative performance metrics and physical/chemical properties established through laboratory testing. For example:

• Shear/Tensile Bond Strength: Measured values against a minimum acceptable MPa.
• Depth of Cure: Measured value against a minimum acceptable mm.
• pH: Measured value within a specified range.
• Appearance/Ease of Application/Occlusion of Dentinal Tubules: Qualitative assessment against defined criteria (e.g., "COMPLIES").

These are not "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic or therapeutic clinical study, but rather engineering and material science specifications.

8. Sample Size for the Training Set:

Not applicable. This document describes a traditional medical device (dental material) and its performance validation, not a machine learning model that would require a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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