[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of prosthetic restorations on implant abutments and frames
[3] Cementation of adhesion bridges and splints
[4] Cementation of posts and cores
[5] Amalgam bonding

Device Description

The subject device is a dual-cure (light- and/or self-cure), fluoride releasing, radiopaque self-adhesive resin cement for ceramic (porcelain, lithium disilicate, zirconia, etc.), composite resin, and metal restorations. It is supplied in an automix delivery system which can mix equal amounts of two components.

AI/ML Overview

The provided text describes the regulatory clearance of a dental cement, PANAVIA SA Cement Plus Automix, and establishes its substantial equivalence to predicate devices, primarily PANAVIA SA CEMENT Automix and PANAVIA F 2.0. The "study" referenced in the text is a set of non-clinical tests performed to demonstrate this equivalence, rather than a clinical study involving human patients.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials) for physical and mechanical properties, and ISO/TS 11405: 2003 for shear bond strengths.

Acceptance Criteria (Standard / Test)	Subject Device Performance (PANAVIA SA Cement Plus Automix)	Predicate Device Performance (PANAVIA SA CEMENT Automix / PANAVIA F 2.0)
ISO 4049: 2009 Performance
5.2.2 Film thickness, luting materials	COMPLIES	COMPLIES
5.2.4 Working time, Class 1 and Class 3 luting materials	COMPLIES	COMPLIES
5.2.6 Setting time, Class 3 materials	COMPLIES	COMPLIES
5.2.9 Flexural strength	COMPLIES	COMPLIES
5.2.10 Water sorption and solubility	COMPLIES	COMPLIES
5.4 Color stability after irradiation and water sorption	COMPLIES	COMPLIES
5.5 Radio-opacity	COMPLIES	COMPLIES
ISO/TS 11405: 2003 Shear Bond Strength
Adherend surface: Tooth dentin (In-house standard criteria)	COMPLIES	COMPLIES
Adherend surface: Tooth enamel (In-house standard criteria)	COMPLIES	COMPLIES
Adherend surface: Ceramic (In-house standard criteria)	COMPLIES	COMPLIES
Adherend surface: Metal (In-house standard criteria)	COMPLIES	COMPLIES
Adherend surface: Titan (In-house standard criteria)	COMPLIES	COMPLIES
Adherend surface: Composite resin (In-house standard criteria)	COMPLIES	COMPLIES
Adherend surface: Amalgam (In-house standard criteria)	COMPLIES	COMPLIES
Released fluorine ion test	Substantially equivalent to predicate device	Baseline for comparison

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

The document does not explicitly state the sample sizes for each specific test or the "test set" in the context of clinical data. The studies are non-clinical, laboratory-based tests. The data provenance is not explicitly stated as country of origin, but the submitting company is Kuraray Noritake Dental Inc. located in Japan and the tests refer to international standards (ISO). The studies are retrospective in the sense that they are laboratory evaluations performed for regulatory submission, not a prospective clinical trial.

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

This information is not applicable as the studies are non-clinical laboratory tests. "Ground truth" in this context refers to established standards and physical measurements, not expert interpretation of clinical images or data.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical laboratory tests. Adjudication methods (like 2+1, 3+1) are typically used for establishing consensus among human readers in clinical studies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This is a non-clinical evaluation of a dental cement, not an AI or imaging diagnostic device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a "standalone" performance study in the context of an algorithm or AI was not done. The device is a dental cement, not a software or AI product. The performance studies describe the material properties in a laboratory setting.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations (physical, mechanical, and bond strength tests) are the established requirements and methodologies of international standards (ISO 4049: 2009 and ISO/TS 11405: 2003) as well as in-house standards for shear bond strength criteria. For biocompatibility, it refers to the requirements of ISO 10993 series and ISO 7405. These are objective, quantitative measurements and adherence to established protocols.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable for this type of non-clinical device evaluation. Training sets are used in machine learning for AI model development.

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

This information is not applicable as there is no training set mentioned or implied in the context of this device's evaluation.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three overlapping profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 27, 2015

Kuraray Noritake Dental Inc. C/O Mr. Goro Asanuma Kuraray America, Inc. 33 Maiden Lane, 6th Floor New York, New York 10038

Re: K142625

Trade/Device Name: PANAVIA SA Cement Plus Automix Regulation Number: 21 CFR 872.3275 Regulation Name: Dental cement Regulatory Class: II Product Code: EMA Dated: December 22, 2014 Received: December 23, 2014

Dear Mr. Asanuma:

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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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

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Indications for Use

510(k) Number (if known): K142625

Device Name: PANAVIA SA Cement Plus Automix

Indications for Use:

[1] Cementation of crowns, bridges, inlays and onlays

[2] Cementation of prosthetic restorations on implant abutments and frames

[3] Cementation of adhesion bridges and splints

[4] Cementation of posts and cores

[5] Amalgam bonding

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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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January 27th, 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	Goro AsanumaKURARAY 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 SA Cement Plus Automix
	2) Classification name	Dental cement(21 CFR section 872.3275. Product code: EMA)
	3) Common name	Dental adhesive resin cement
	3-3. Predicate devices
1)	PANAVIA SA CEMENT Automix	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	K120379Dental cementEMA872.3275Kuraray Noritake Dental Inc.
2)	PANAVIA F 2.0	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	K032455Dental 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 TRI-S BOND	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	K042913Resin tooth bonding agentKLE872.3200Kuraray Noritake Dental Inc.
5)	CLEARFIL DC CORE PLUS	510(k) Number:Classification:Product Code:21 CFR Section:Applicant:	K111982Tooth shade resin materialEBF872.3690Kuraray Noritake Dental Inc.

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3-4. Device Description

This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.

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 prosthetic restorations on implant abutments and frames
[3] Cementation of adhesion bridges and splints
[4] Cementation of posts and cores
[5] Amalgam bonding

3-6. Substantial Equivalence Discussion

1. Intended uses
  Intended uses of the subject device and predicate devices, PANAVIA SA CEMENT Automix which is self-adhesive resin cement and PANAVIA F2.0 which is dental resin cement, are as listed on the following table.

	Trade name	Intended use
Subjectdevice	PANAVIA SACement Plus Automix	[1] Cementation of crowns, bridges, inlays and onlays[2] Cementation of prosthetic restorations on implant abutmentsand frames[3] Cementation of adhesion bridges and splints[4] Cementation of posts and cores[5] Amalgam bonding
Predicatedevices	PANAVIA SACEMENT Automix	[1] Cementation of crowns, bridges, inlays and onlays made ofporcelain, ceramic, composite resin or metal[2] Cementation of porcelain, ceramic, composite resin or metalrestorations on implant abutments[3] Cementation of metal cores, resin cores, metal posts or glassfiber posts
	PANAVIA F2.0	[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

The intended use of the subject device was written up based on those of the predicate devices. The implant abutments and frames are made of the same materials. Their required adhesive performance is same. The adhesion bridges and splints are also made of the same materials. Their required adhesive performance is same, too.

Therefore, the intended use of the subject device is substantially equivalent to those of the predicate devices.

Chemical ingredients/ Safety

Except for 5 chemical ingredients all ingredients in the subject device have been used in 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.

The subject device contains new 5 ingredients. Therefore, we evaluated the subject device referring to 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 device.

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	PANAVIA SA Cement PlusAutomix (Subject device)		PANAVIA SA CEMENTAutomix (Predicate device)
	Shade type:Universal (A2)	Shade type :White	Shade type:Universal (A2)	Shade type :White
5.2.2 Film thickness, luting materials	COMPLIES	COMPLIES	COMPLIES	COMPLIES
5.2.4 Working time, Class 1 and Class3 luting materials	COMPLIES	COMPLIES	COMPLIES	COMPLIES
5.2.6 Setting time, Class 3 materials	COMPLIES	COMPLIES	COMPLIES	COMPLIES
5.2.9 Flexural strength	COMPLIES	COMPLIES	COMPLIES	COMPLIES
5.2.10 Water sorptionand solubility	COMPLIES	COMPLIES	COMPLIES	COMPLIES
5.4 Color stability after irradiation andwater sorption	COMPLIES	COMPLIES	COMPLIES	COMPLIES
5.5 Radio-opacity	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 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 substrates which are matched to each indication referring to ISO/TS 11405: 2003 were indicated below.

Adherend surface(Material composition)	Criteria	Shear bond strength
		Subject device	Predicate device
Tooth dentin	In-housestandard	COMPLIES	COMPLIES
Tooth enamel		COMPLIES	COMPLIES
Ceramic		COMPLIES	COMPLIES
Metal		COMPLIES	COMPLIES	PANAVIA SA Cement
Titan		COMPLIES	COMPLIES
Composite resin		COMPLIES	COMPLIES
Amalgam		COMPLIES	COMPLIES	PANAVIA F 2.0

The shear bond strengths to all substrates of the subject device were not statistically (P>0.05) different from those of the predicate devices.

Therefore, it was concluded that the bonding performance to all substrates of the subject device was equivalent to those of the predicate devices.

Released fluorine ion test was performed to validate the substantial equivalence of the subject device with the predicate device.

It was concluded that amount of released fluorine ion from the subject device is substantially equivalent to those from the predicate device.

3-7. Biocompatibility

The subject device is classified according to ISO 7405:2008 and ISO 10993-1:2009 as an external communicating device that will have permanent (> 30 days) contact with tissues. We performed the biological safety tests of the subject device. As a result of the tests, it was concluded that the subject device is substantially equivalent in biological safety to the predicate device.

3-8. Conclusion

The comparison for intended uses, chemical ingredients/ safety and performance data shows that the subject device is substantially equivalent to the predicate devices.

This submission information including the nonclinical testing provided supports that the subject device is as safe and as effective as the predicate devices.

Regulation Number and Section

§ 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.