(156 days)
[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 and frames
[5] Cementation of posts and cores
[6] Amalgam bonding
The subject device is an adhesive resin cement system. It consists of the cement paste (Paste), Try-in Paste, Tooth Primer, CLEARFIL CERAMIC PRIMER PLUS and K-ETCHANT Syringe. The Paste is a dual-cure (light- and/or self-cure), fluoride-releasing, radiopaque resin cement for ceramics (lithium disilicate, zirconia, etc.), hybrid ceramics, composite resins, and metal restorations. It is supplied in an automix delivery system which mixes equal amounts of two components. It is available in the following 5 shades; Universal (A2), Clear, Brown (A4), White, and Opaque. The Opaque shade should be self-cured for final curing due to its strong opacity. The Try-in Paste is a shade matching material which has approximate color and transparency as the hardened mixture of Paste. The Tooth Primer is a self-etching primer to tooth structures that accelerates the polymerization of the Paste.
The provided text is a 510(k) Summary for the dental cement "PANAVIA V5". It describes the device, its intended use, and comparative studies against predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Section | Requirement | PANAVIA V5 (Subject device) Performance | Acceptance Criteria Met? |
|---|---|---|---|
| 5.2.2 Film thickness, luting materials | < 50 μm | COMPLIES (for all shades: Universal (A2), White, Opaque) | Yes |
| 5.2.4 Working time, Class 1 and Class 3 luting materials | > 60 seconds | COMPLIES (for all shades) | Yes |
| 5.2.5 Setting time, Class 1 materials or 5.2.6 Setting time, Class 3 materials | < 10 min | COMPLIES (for all shades) | Yes |
| 5.2.9 Flexural strength | ≥ 50 MPa | COMPLIES (for all shades) | Yes |
| 5.2.10 Water sorption | ≤ 40 μg/mm³ | COMPLIES (for all shades) | Yes |
| 5.2.10 Solubility | ≤ 7.5 μg/mm³ | COMPLIES (for all shades) | Yes |
| 5.4 Color stability after irradiation and water sorption | No more than a slight change in color shall be observed | COMPLIES (for all shades) | Yes |
| 5.5 Radio-opacity | Equal to or greater than that of the same thickness of aluminum | COMPLIES (for all shades) | Yes |
| Shear Bond Strength (to Dentin) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Enamel) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Metal) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Composite resin) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Ceramic) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Hybrid ceramics) | In-house standard | COMPLIES | Yes |
| Shear Bond Strength (to Amalgam) | In-house standard | COMPLIES | Yes |
| Released fluorine ion test | Lower than that by PANAVIA F2.0 (predicate device) | Confirmed that the released level from the cured one by the subject device was lower than that by PANAVIA F2.0. | Yes |
| Biocompatibility | Compliance with ISO 10993 series and ISO 7405 (Cytotoxicity, Sub-chronic systemic toxicity, Skin irritation, Sensitization, Genotoxicity) | Paste and Tooth Primer: Concluded to be substantially equivalent in biocompatibility to predicate devices. Try-in Paste: Concluded to be substantially equivalent. | Yes |
2. Sample sizes used for the test set and the data provenance
The document does not specify exact sample sizes for each test in the performance evaluation. It only states that tests were performed "according to ISO 4049: 2009" and "ISO/TS 11405: 2003" and that "in-house standard" was used for shear bond strengths. It does not provide information on the country of origin of the data or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies conducted are primarily in-vitro physical, mechanical, and biological tests, not studies relying on expert clinical assessment for ground truth.
4. Adjudication method for the test set
This information is not applicable as the studies are in-vitro tests and do not involve human adjudication of results in the way a clinical study with image interpretation, for example, would. The results are based on objective measurements against international standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This document is for a dental cement, and such studies are typically performed for diagnostic imaging AI devices, not for material properties.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a dental cement, not an AI algorithm. The performance evaluation focuses on the material's physical, mechanical, and biological properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance criteria is based on:
- International Standards: ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials) and ISO/TS 11405: 2003 (Dentistry - Testing of adhesion to tooth structure and dental restorative materials).
- In-house standards: For shear bond strength tests.
- Biocompatibility Standards: ISO 10993 series and ISO 7405.
These standards define the acceptable range or benchmark for different physical, mechanical, and biological properties.
8. The sample size for the training set
This question is not applicable. The device is a dental cement, and there is no "training set" in the context of an AI algorithm creating a model from data. The tests are direct measurements of the material's properties.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2015
Kuraray Noritake Dental, Inc. Mr. Michio Takigawa Manager Ote Center Bldg. 7F, 1-1-3Otemachi Chiyoda-ku, Tokyo 100-0004 JAPAN
Re: K150704 Trade/Device Name: Panavia V5 Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: July 21, 2015 Received: July 23, 2015
Dear Mr. Takigawa:
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. 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.
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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 2: Indications for Use
Indications for Use
510(k) Number (if known): K150704
Device Name: PANAVIA V5
Indications for Use:
[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 and frames
[5] Cementation of posts and cores
[6] Amalgam bonding
| Prescription Use | ✓ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use N/A (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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[PANAVIA V5, Kuraray Noritake Dental Inc.] Section 3: Summary
August 13, 2015 Date:
510(k) Summary
3-1. 510(k) owner (submitter)
| 1) | Name | Kuraray Noritake Dental Inc. | |
|---|---|---|---|
| 2) | Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan | |
| 3) | Contact person | Michio TakigawaQuality Assurance Department | |
| 4) | Contact person in US | Shinichi SatoKURARAY AMERICA, INC.33 Maiden Lane, 6th Floor, New York, NY 10038Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676Fax: (212)-867-3543 | |
| 3-2. Name of Device | |||
| 1) | Trade / Proprietary name | PANAVIA V5 | |
| 2) | Classification name | Dental cement(21 CFR section 872.3275. Product code: EMA) | |
| 3) | Common name | Adhesive resin cement system | |
| 3-3. Predicate devices | |||
| 1) | PANAVIA F 2.0 (Primary predicate) | 510(k) Number:Classification:Product Code:21 CFR Section:Applicant: | K032455Dental cementEMA872.3275Kuraray Noritake Dental Inc. |
| 2) | PANAVIA SA Cement Plus Automix | 510(k) Number:Classification:Product Code:21 CFR Section:Applicant: | K142625Dental cementEMA872.3275Kuraray Noritake Dental Inc. |
| 3) | CLEARFIL AP-X | 510(k) Number:Classification:Product Code:21 CFR Section:Applicant: | K012740Tooth shade resin materialEBF872.3690Kuraray Noritake Dental Inc. |
| 4) | CLEARFIL ESTHETIC CEMENT EX | 510(k) Number:Classification:Product Code:21 CFR Section:Applicant: | K062410Dental cementEMA872.3275Kuraray Noritake Dental Inc. |
| 5) | ESTENIA C&B | 510(k) Number:Classification:Product Code:21 CFR Section:Applicant: | K042929Tooth shade resin materialEBF872.3690Kuraray Noritake Dental Inc. |
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- CLEARFIL SE Protect
510(k) Number: Classification: Product Code: 21 CFR Section: Applicant:
K033938 Resin Tooth Bonding Agent KLE 872.3200 Kuraray Noritake Dental Inc.
3-4. Device Description
The subject device is an adhesive resin cement system. It consists of the cement paste (Paste), Try-in Paste, Tooth Primer, CLEARFIL CERAMIC PRIMER PLUS and K-ETCHANT Syringe. The Paste is a dual-cure (light- and/or self-cure), fluoride-releasing, radiopaque resin cement for ceramics (lithium disilicate, zirconia, etc.), hybrid ceramics, composite resins, and metal restorations. It is supplied in an automix delivery system which mixes equal amounts of two components. It is available in the following 5 shades; Universal (A2), Clear, Brown (A4), White, and Opaque. The Opaque shade should be self-cured for final curing due to its strong opacity. The Try-in Paste is a shade matching material which has approximate color and transparency as the hardened mixture of Paste. The Tooth Primer is a self-etching primer to tooth structures that accelerates the polymerization of the Paste.
This is the new registration application for the subject device.
Concerning CLEARFIL CERAMIC PRIMER PLUS and K-ETCHANT Syringe, the specification of those 2 components were omitted for the reasons set forth below.
We already have had 510(k) clearance of K-ETCHANT Syringe (510(k) Number: 133078). And we submit the application for CLEARFIL CERAMIC PRIMER PLUS as separate application at the same time.
3-5. Statement of Intended Use
The subject device is indicated for the following uses:
- [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 and frames
- [5] Cementation of posts and cores
- [6] Amalgam bonding
3-6. Substantial Equivalence Discussion
- Intended uses
The INDICATIONS of the subject device and predicate devices, PANAVIA F2.0 which is dental resin cement and PANAVIA SA Cement Plus Automix which is self-adhesive resin cement, are as listed on the following table.
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| Trade name | Intended use | |
|---|---|---|
| Subjectdevice | PANAVIA V5 | [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 | PANAVIA F2.0(Primary predicate) | [1] Cementation of metal crowns and bridges, inlays and onlays[2] Cementation of porcelain crowns, inlays, onlays and veneers[3] Cementation of composite resin crowns, inlays, and onlays[4] Cementation of adhesion bridges[5] Cementation of endodontic cores and prefabricated posts[6] Amalgam bonding |
| PANAVIA SACement Plus Automix | [1] Cementation of crowns, bridges, inlays and onlays[2] Cementation of prosthetic restorations on implant abutments andframes[3] Cementation of adhesion bridges and splints[4] Cementation of posts and cores[5] Amalgam bonding |
The intended use of the subject device was written up based on those of the predicate devices. Therefore, the intended use of the subject device is substantially equivalent to those of the predicate devices
- Chemical ingredients
Except for 5 chemical ingredients, all ingredients in the Paste and Tooth Primer are identical and have been used in the following predicate devices: K032455 Panivia 2.0, K142625 Panavia SACement, K012740 Clearfil AP-X, K062410 Clearfil Esthetic Cement and DC Bond, K033938 Clearfil Protect Bond and K042929 Estenia C&B.
Regarding these predicate devices, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US.
5 chemical ingredients in the Paste and Tooth Primer are new ingredients.
Therefore, we evaluated the Paste and Tooth Primer referring to ISO 10993 series and ISO 7405. As a result of the tests, it was concluded that the Paste and Tooth Primer is substantially equivalent in biocompatibility to the predicate devices.
All the chemical ingredients of the Try-in Paste are identical to those of the predicate devices. Regarding the predicate 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 Try-in Paste was substantially equivalent to the predicate devices.
-
- 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). According to ISO 4049: 2009, the subject device is classified into the following:
- Technological characteristics/ Effectiveness and Performance
Shade type: Universal (A2), Clear, Brown (A4), White
Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present
Shade type: Opaque
Class 1: materials whose setting is effected by mixing an initiator and activator.
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| The results of comparative study performed according to ISO 4049: 2009 were indicated below. | |||||||
|---|---|---|---|---|---|---|---|
| Section | Requirement | PANAVIA V5 (Subject device) | PANAVIA F2.0 (Primary predicate) | ||||
| Shade type:Universal (A2)Class 3 | Shade type :WhiteClass 3 | Shade type :OpaqueClass 1 | Shade type:BrownClass 3 | Shade type:OpaqueClass 1 | |||
| 5.2.2 Filmthickness, lutingmaterials | <50μm | COMPLIES | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.2.4 Working time,Class 1 and Class3 luting materials | >60 seconds | COMPLIES | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.2.5 Setting time,Class 1 materialsor5.2.6 Setting time,Class 3 materials | <10 min | COMPLIES | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.2.9 Flexuralstrength | ≥50 MPa | COMPLIES | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.2.10 | Watersorption | ≤40µg/mm³ | COMPLIES | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| Solubility | ≤7.5µg/mm³ | COMPLIES | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.4 Color stabilityafter irradiationand water sorption | No morethan a slightchange incolor shall beobserved | COMPLIES | COMPLIES | COMPLIES | COMPLIES | COMPLIES | |
| 5.5 Radio-opacity | Equal to orgreater thanthat of thesamethickness ofaluminum | COMPLIES | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
The results of comparative study nerformed according to ISO 4049; 2009 were indicated below
"COMPLIES" means that test values were in the acceptable range to pass the testing in compliance with the requirements of ISO 4049: 2009.
The results indicate that the subject device and the predicate device 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 device.
| The shear bond strengths for the adherent surfaces which are matched to each indication in accordance | ||
|---|---|---|
| with ISO/TS 11405: 2003 were indicated below. |
| Adherent surface(Material composition) | PRIMER | Criteria | Subject device(Universal (A2)) | Primary predicate(PANAVIA F 2.0) |
|---|---|---|---|---|
| Dentin | Tooth Primer | In-house standard | COMPLIES | COMPLIES |
| Enamel | COMPLIES | COMPLIES | ||
| Metal | COMPLIES | COMPLIES | ||
| Composite resin | COMPLIES | COMPLIES | ||
| Ceramic | CLEARFILCERAMICPRIMER | COMPLIES | COMPLIES | |
| Hybrid ceramics | COMPLIES | COMPLIES | ||
| Metal | COMPLIES | COMPLIES | ||
| Composite resin | PLUS | COMPLIES | COMPLIES | |
| DentinAmalgam | Tooth PrimerN/A | COMPLIES | COMPLIES |
"COMPLIES" means that test values were in the acceptable range to pass the testing in compliance with the requirements of in-house standard.
It was concluded that the bonding performance to all substrates of the subject device was equivalent to those of the predicate device.
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Released fluorine ion test was performed to validate the substantial equivalence of the subject device with the predicate device in terms of performance for the intended uses.
It was confirmed that the released level from the cured one by the subject device was lower than that by PANAVIA F2.0.
3-7. Biocompatibility
Paste and Tooth Primer are categorized into the external communicating device (tissue/ bone/ dentin) and permanent contact device.
Except for 5 chemical ingredients, all ingredients in the Paste and Tooth Primer have been used in the predicate devices.
Regarding these predicate devices, there have not been any reported problems or recalls according to the nost market adverse event reporting requirements in the US.
5 chemical ingredients in the Paste and Tooth Primer are new ingredients.
Therefore, we evaluated the Paste and Tooth Primer referring to ISO 10993 series and ISO 7405. We decided to perform the following tests.
- Cytotoxicity test a)
- b) Sub-chronic systemic toxicity test
- Skin irritation and intra-cutaneous reactivity test (oral mucosa irritation test) c)
- d) Sensitization test (skin sensitization test)
- Genotoxicity test (reverse mutation test, chromosomal aberration test) e)
As a result of the tests, it was concluded that the Paste and Tooth Primer are substantially equivalent in biocompatibility to the predicate devices.
Try-in Paste is categorized into the external communicating device that may contact dentin and whose duration of contact is less than 24 hours.
All the chemical ingredients of the Try-in Paste are identical to those of the predicate devices.
Regarding the predicate 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 Try-in Paste was substantially equivalent to the predicate devices.
3-8. Conclusion
The comparison for intended uses, chemical ingredients and performance data shows that the subject device is substantially equivalent to the predicate 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.