(109 days)
Cementation of ceramic and composite inlays, onlays and laminate veneers with less than 2mm thickness
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).
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 11, 2021
Kuraray Noritake Dental Inc. Yasujiro Ohara Manager Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku, Tokyo 100-0004 JAPAN
Re: K210504/S001
Trade/Device Name: PANAVIA Veneer LC Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: April 13, 2021 Received: April 16, 2021
Dear Yasujiro Ohara:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210504
Device Name PANAVIA Veneer LC
Indications for Use (Describe)
[1] Cementation of ceramic and composite inlays, onlays and laminate veneers with less than 2mm thickness
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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10th June, 2021 Date:
510(k) Summary: K210504
5-1. 510(k) owner (submitter)
| 1) Name | Kuraray Noritake Dental Inc. |
|---|---|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan |
| 3) Contact person | Yasujiro Ohara |
| ManagerQuality Assurance Department | |
| 4) Contact person in US | Manabu SuzukiDirectorDental Material DivisionKURARAY AMERICA, INC.33 Maiden Lane, 6th Floor, New York, NY 10038Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676Fax: (212)-867-3543 |
| 5-2. Name of Device | |
| 1) Trade / Proprietary name | PANAVIA Veneer LC |
| 2) Classification name | Dental cement(21 CFR section section: 872.3275. Product code: EMA) |
| 3) Common name | Dental adhesive resin cement |
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| 5-3. Predicate devices | ||
|---|---|---|
| 1) PANAVIA V5(Primary predicate device) | 510(k) Number: | K150704 |
| Classification: | Dental cement | |
| Product Code: | EMA | |
| 21 CFR Section: | 872.3275 | |
| Applicant: | Kuraray Noritake Dental Inc. | |
| 2) CLEARFIL MAJESTY ES Flow(Predicate device) | 510(k) Number: | K191980 |
| Classification: | Tooth shade resin material | |
| Product Code: | EBF | |
| 21 CFR Section: | 872.3690 | |
| Applicant: | Kuraray Noritake Dental Inc. | |
| 3) CLEARFIL Universal BondQuick(Reference device) | 510(k) Number: | K161042 |
| Classification: | Resin tooth bonding agent | |
| Product Code: | KLE | |
| 21 CFR Section: | 872.3200 | |
| Applicant: | Kuraray Noritake Dental Inc. | |
| 4) KATANA AVENCIA Block(Reference device) | 510(k) Number: | K153476 |
| Classification: | Tooth shade resin material | |
| Product Code: | EBF | |
| 21 CFR Section: | 872.3690 | |
| Applicant: | Kuraray Noritake Dental Inc. |
The relationship between the subject device and each device are shown as follows.
| The Relationship between the subject device and each device are shown as follows: | |
|---|---|
| PANAVIA V5(Primary predicate device) | According to ISO 4049: 2009, this predicate device isclassified as dual-cure (light-curing and self-curing)luting material (Type 2 - Class 3 - Group 1).The subject device is classified as light-curing lutingmaterial (Type 2 - Class 2 - Group 1). Therefore,The predicate device has the same performance forlight-curing luting material as the subject device.Intended use and technological characteristics arealmost same as the subject device. |
| CLEARFIL MAJESTY ES Flow(Predicate device) | According to ISO 4049: 2009, this predicate device isclassified as a Type 2 - Class 2 - Group 1 lutingmaterial when using for cementation as same as thesubject device.Intended use and technological characteristics forcementation are almost same as the subject device. |
| CLEARFIL Universal Bond Quick(Reference device) | Those devices are chosen to explain the Equivalenceof Safety for Chemical Ingredient. |
| KATANA AVENCIA Block(Reference device) | And those are the same category (the externalcommunicating device (tissue/ bone/ dentin) andpermanent contact device) as the subject device. |
5-4. Device Description
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
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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).
5-5. Statement of Intended Use
The subject device is indicated for the following uses:
- [1] Cementation of ceramic and composite inlays, onlays and laminate veneers with less than 2mm thickness
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5-6. Substantial Equivalence Discussion
1) Intended uses
| Trade name | Intended use | |
|---|---|---|
| Subjectdevice | PANAVIA Veneer LC | [1] Cementation of ceramic and composite inlays,onlays and laminate veneers with less than 2mmthickness |
| Predicatedevices | PANAVIA V5(Primary predicatedevice) | [1] Cementation of crowns, bridges, inlays and onlays[2] Cementation of veneers[3] Cementation of adhesion bridges and splints[4] Cementation of prosthetic restorations on implant abutments andframes[5] Cementation of posts and cores[6] Amalgam bonding |
| Predicatedevices | CLEARFILMAJESTY ES Flow(Predicate device) | [1] Direct restorations for all cavity classes, cervicallesions (e.g. root surface caries, v-shape defects),tooth wear, and tooth erosion[2] Cavity base / liner[3] Correction of tooth position and tooth shape (e.g.diastema closure, tooth malformation)[4] Intraoral repair of fractured restorations[5] Cementation of ceramic and composite inlays,onlays and veneers with less than 2mm thickness |
The intended use of the subject device and the predicate devices are listed on the following table.
The intended use of the subject device was written up based on the Intended use [1] and [2] of primary predicate device and the Intended use [5] of Predicate device.
Therefore, the intended use of the subject device is substantially equivalent to those of the predicate devices.
2) Chemical ingredients/ Safety
Except for new ingredients, all ingredients have been used in the predicate devices as described in "Section 12: Substantial Equivalence Discussion". Regarding these predicate devices and reference devices, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US.
We evaluated the subject device referring to "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff", ISO 10993 series and ISO 7405. As a result of the tests, it was concluded that the subject device is substantially equivalent in biological safety to the predicate devices and reference devices.
-
- Comparison of Technological characteristics/ Effectiveness and Performance Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials).
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| Section | Requirement | PANAVIA Veneer LC(Subject device) | PANAVIA V5(Primarypredicatedevice) | CLEARFILMAJESTY ESFlow(Predicatedevice) | |
|---|---|---|---|---|---|
| Shade type 1:ClearClass 2 | Shade type 2:WhiteClass 2 | Shade type:Universal(A2)Class 3 | Class 2 | ||
| 5.2.2 Filmthickness, lutingmaterials | <50μm. | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| 5.2.7 Sensitivity toambient light | The material shallremain physicallyhomogeneous. | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| 5.2.8 Depth of cure | Shade type 1 andPredicate device:Not less than 1.5mm.Shade type 2:Not less than 1.0mm. | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| 5.2.9 Flexuralstrength | Equal to or greaterthan 50 MPa. | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| 5.2.10 Watersorption andsolubility | ≤40 μg/mm³. | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| ≤7.5 μg/mm³. | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.4 Color stabilityafter irradiationand watersorption | No more than a slightchange in color shallbe observed for lutingmaterials. | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| 5.5 Radio-opacity | Equal to or greaterthan that of the samethickness ofaluminium and no lessthan 0.5 mm of anyvalue claimed by themanufacturer. | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
The results of comparative study performed according to ISO 4049: 2009 were indicated below.
The results indicate that the subject device and the predicate devices comply with the requirements of ISO 4049: 2009. From the above, it can be said that comparative study of the subject device is substantially equivalent to that of the predicate devices.
| The result of Bond strength test | ||||
|---|---|---|---|---|
| -- | -- | -- | ---------------------------------- | -- |
| Adherend surface(Material composition) | Criteria | Subject device | Primary predicate device | |
|---|---|---|---|---|
| Tooth dentin | In-housestandard | COMPLIES | COMPLIES | PANAVIA V5 |
| Tooth enamel | COMPLIES | COMPLIES | ||
| Ceramic | COMPLIES | COMPLIES | ||
| Composite resin | COMPLIES | COMPLIES | ||
| Hybrid ceramic | COMPLIES | COMPLIES |
The bond strengths to all substrates of the subject device were not statistically (P>0.05) different from that of the primary predicate device.
Therefore, it was concluded that the bonding performance to all substrates of the subject device was equivalent to that of the predicate device.
Released fluorine ion test was performed to validate the substantial equivalence of the subject device with the primary predicate device.
It was concluded that amount of released fluorine ion from the subject device is substantially equivalent to that of the predicate device.
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5-7. Biocompatibility
The subject device is categorized into the external communicating device (tissue/ bone/dentin) and permanent contact device. There are new ingredients in the subject device.
Therefore, we evaluated the subject device referring to "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff", ISO 10993 series and ISO 7405. The above results led us to the conclusion that the subject device was substantially equivalent in safety to the predicate devices and reference devices.
On the other hand, except for new ingredients on the subject device, all ingredients in the subject device have been used in the predicate device and the reference devices as described in "Section 12: Substantial Equivalence Discussion"
Regarding these the predicate device and the reference devices, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US.
Accordingly, it was considered that the subject device was substantially equivalent in safety to the predicate devices and reference devices.
5-8. Conclusion
The comparison for intended uses, chemical ingredients/ safety and performance data shows that the subject device is substantially equivalent to the predicate devices and reference devices. This submission information including the nonclinical testing provided supports that the subject device is as safe and as effective as the predicate devices.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.