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PANAVIA Veneer LC is a light-cure adhesive resin cement system. It consists of the light-cure cement paste (PANAVIA Veneer LC paste), CLEARFIL CERAMIC PRIMER PLUS, K-ETCHANT Syringe, and PANAVIA V5 Try-in Paste. CLEARFIL Universal Bond Quick or PANAVIA V5 Tooth Primer can be chosen for tooth treatment.

The cement paste is a light-cure, resin based material which provides color stability and has radiopacity equal to or greater than 1mm aluminum. It is indicated for inlays, onlays and laminate veneer restorations made of ceramic and composite resin. It is supplied in Kuraray's ergonomic syringe and dispensed via an angled applicator tip (16G) into an inlay cavity or onto an onlay or a laminate veneer. It is available in 4 shades; Universal (A2), Clear, Brown (A4) and White. It is classified as a Type 2 and Class 2 (Group 1) material by ISO 4049. Shade adaptation is available to check by PANAVIA V5 Try-in Paste before cementation. This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.

We are seeking clearance for PANAVIA Veneer LC paste in this submission.

Concerning Try-in Paste which is included as components of the PANAVIA V5, CLEARFIL Universal Bond Quick, CLEARFIL CERAMIC PRIMER PLUS and K-ETCHANT Syringe, the specification of those 4 components were omitted for the reasons set forth below.

We already have had 510(k) clearance of Try-in Paste of PANAVIA V5(510(k) Number: 150704), CLEARFIL Universal Bond Quick (510(k) Number: 161042), CLEARFIL CERAMIC PRIMER PLUS (510(k) Number: 150703) and K-ETCHANT Syringe (510(k) Number: 133078).

AI/ML Overview

This document describes the marketing authorization for the PANAVIA Veneer LC dental cement. Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Section	Requirement	PANAVIA Veneer LC (Subject device)	PANAVIA V5 (Primary predicate device)	CLEARFIL MAJESTY ES Flow (Predicate device)
5.2.2 Film thickness, luting materials	< 50 μm.	COMPLIES	COMPLIES	COMPLIES
5.2.7 Sensitivity to ambient light	The material shall remain physically homogeneous.	COMPLIES	COMPLIES	COMPLIES
5.2.8 Depth of cure	Shade type 1 and Predicate device: Not less than 1.5mm. Shade type 2: Not less than 1.0mm.	COMPLIES	COMPLIES	COMPLIES
5.2.9 Flexural strength	Equal to or greater than 50 MPa.	COMPLIES	COMPLIES	COMPLIES
5.2.10 Water sorption and solubility	≤ 40 μg/mm³.	COMPLIES	COMPLIES	COMPLIES
	≤ 7.5 μg/mm³.	COMPLIES	COMPLIES	COMPLIES
5.4 Color stability after irradiation and water sorption	No more than a slight change in color shall be observed for luting materials.	COMPLIES	COMPLIES	COMPLIES
5.5 Radio-opacity	Equal to or greater than that of the same thickness of aluminium and no less than 0.5 mm of any value claimed by the manufacturer.	COMPLIES	COMPLIES	COMPLIES

Bond Strength Test

Adherend surface (Material composition)	Criteria	Subject device	Primary predicate device (PANAVIA V5)
Tooth dentin	In-house standard	COMPLIES	COMPLIES
Tooth enamel		COMPLIES	COMPLIES
Ceramic		COMPLIES	COMPLIES
Composite resin		COMPLIES	COMPLIES
Hybrid ceramic		COMPLIES	COMPLIES

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

The document does not explicitly state the specific sample sizes used for each individual test within the comparative study according to ISO 4049: 2009 or the bond strength test. The data provenance is implied to be from internal studies conducted by Kuraray Noritake Dental Inc., as indicated by "In-house standard" for the bond strength criteria. The country of origin of the device manufacturer is Japan. The studies are assumed to be prospective in nature, conducted specifically for the purpose of this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This document does not describe the use of human experts or ground truth establishment in the context of diagnostic interpretation or clinical decision-making. The "ground truth" here refers to objective physical and mechanical properties measured and compared against established ISO standards and in-house standards. Therefore, information regarding experts and their qualifications for establishing ground truth is not applicable to this type of device and study.

4. Adjudication Method for the Test Set

Not applicable. The studies involve objective measurements of material properties against predefined standards, not subjective interpretations requiring adjudication.

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

Not applicable. This device is a dental cement, and its performance is evaluated based on physical and mechanical properties, not by human readers interpreting medical images or data. Therefore, an MRMC study and effect size of AI assistance are not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a dental cement, not an algorithm or AI-powered system. The studies described evaluate the intrinsic properties of the material.

7. Type of Ground Truth Used

The ground truth used for the subject device's performance evaluation against acceptance criteria is based on:

International Standards: Specifically, ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials).
In-house Standards: For the bond strength test.
Comparative Data: Performance of the predicate devices (PANAVIA V5 and CLEARFIL MAJESTY ES Flow) serve as a comparative ground truth to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device is a dental cement, not a machine learning model. Therefore, there is no "training set" in the context of artificial intelligence.

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

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

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