[1] Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
[2] Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
[3] Cementation of metal cores, resin cores, metal posts or glass fiber posts

Device Description

PANAVIA SA CEMENT Automix is a dual-cure (light- and/or self-cure), radiopaque self-adhesive resin cement for porcelain, ceramic, composite resin and metal restorations. It is supplied in an automix delivery system which can mix equal amount of two components.

AI/ML Overview

The provided text describes a 510(k) submission for a dental cement (PANAVIA SA CEMENT Automix) and explicitly states that it complies with ISO 4049: 2009. However, the document does not present specific acceptance criteria in a table format with corresponding device performance data, nor does it detail a study that proves the device meets specific acceptance criteria in the manner requested (e.g., sample size, ground truth, expert adjudication, MRMC studies, standalone performance).

The information available is primarily focused on demonstrating substantial equivalence to predicate devices rather than proving performance against quantitative acceptance criteria through a detailed study.

Here's an analysis of what is provided, and where information is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Available Information: The document states, "PANAVIA SA CEMENT Automix complies with all requirements of ISO 4049: 2009 as polymer-based restorative materials." It also mentions, "And also, the bond strength of the subject device is equivalent to that of the predicate devices."
Missing Information/Cannot Create Table: The specific requirements of ISO 4049: 2009 (e.g., flexural strength, water sorption, solubility, film thickness, radiopacity) are not detailed, nor are the actual measured performance values for PANAVIA SA CEMENT Automix presented alongside those specific ISO requirements. The document only provides a high-level statement of compliance. No numerical acceptance criteria or performance data are given for "bond strength."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing Information: This information is not provided in the document. The text does not describe a "test set" in the context of clinical or performance evaluation with a specified sample size or data provenance. The assessment is based on compliance with ISO standards and chemical ingredient comparison, not a "test set" in the typical sense for AI/medical device performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing Information: Not applicable to the type of information presented. This document is related to material properties and substantial equivalence, not a diagnostic device requiring expert ground truth for image interpretation or similar tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing Information: Not applicable for the reasons stated above.

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

Missing Information: Not applicable. This is not an AI-assisted diagnostic device, but a dental cement.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Missing Information: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Available Information (Implicit): The "ground truth" for this device's performance relies on ISO 4049: 2009 standards for physical and mechanical properties, and chemical ingredient equivalence to predicate devices. For bond strength, the "ground truth" appears to be comparative testing against predicate devices.
Missing Information: Specific details of these "ground truths" (e.g., the specific parameters from ISO 4049: 2009, the methodology for comparing bond strength) are not provided.

8. The sample size for the training set

Missing Information: Not applicable as this document is not about an AI/ML device with a "training set."

9. How the ground truth for the training set was established

Missing Information: Not applicable.

Summary of Device Acceptance Criteria and Study Information (Based on provided text):

Acceptance Criteria:

Criterion Category	Specifics (from text)
Material Properties	Compliance with ISO 4049: 2009 for polymer-based restorative materials. The subject device is classified as Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present.
Effectiveness/Performance	Bond strength equivalent to predicate devices.
Chemical Ingredients / Safety	All chemical ingredients are the same as predicate device (CLEARFIL SA CEMENT). No reported problems or recalls for predicate device.
Biocompatibility	All chemical ingredients are the same as predicate device (CLEARFIL SA CEMENT). No reported problems or recalls for predicate devices.
Intended Uses	Indications for use are substantially the same as predicate devices.

Study and Performance Information:

Feature	Details (from text)
Reported Device Performance	- Complies with all requirements of ISO 4049: 2009. - Bond strength is equivalent to that of predicate devices.
Sample Size (Test Set)	Not specified (no clinical or performance test set described in detail).
Data Provenance (Test Set)	Not specified.
Number of Experts (Ground Truth)	Not applicable (device evaluation is based on standards compliance and chemical composition, not expert interpretation).
Qualifications of Experts	Not applicable.
Adjudication Method (Test Set)	Not applicable.
MRMC Comparative Effectiveness Study?	No.
Standalone Performance Study?	No (this refers to an algorithm's performance; the device is a material). Its "standalone performance" is compliance with ISO 4049.
Type of Ground Truth Used	- ISO 4049: 2009 standards for physical/mechanical properties. - Chemical composition equivalence. - Comparative bond strength data (details not provided).
Sample Size (Training Set)	Not applicable.
Ground Truth for Training Set	Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the date March 30, 2012, written in the bottom left corner. Above the date, there is a handwritten number that appears to be K120379. The number is written in a cursive style, and the letters and numbers are connected. The image is a close-up of the date and number, and the background is white.

[PANAVIA SA CEMENT Automix, KURARAY MEDICAL INC.] Section 3: Summary

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January 31, 2012 Date:

3-1. 510(k) owner (submitter)

Name

Address
Contact person
Contact person in U.S.

KURARAY MEDICAL INC.

510(k) Summary

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

Kiyoyuki Arikawa KURARAY AMERICA INC. 600 Lexington Avenue, 26th Floor New York, NY 10022 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543

3-2. Name of Device

Trade / Proprietary name
Classification name
Čonin si nislo

3-3. Predicate device

CLEARFIL SA CEMENT
RelyX Unicem 2

3) PANAVIA F 2.0

PANAVIA SA CEMENT Automix

Dental cement (21 CFR section 872.3275. Product code: EMA)

bumal a interve rerin comoni

510(k) Number: K081583 Product Code: EMA 21 CFR Section: 872. 3275 Applicant: KURARAY MEDICAL INC.

510(k) Number: K100756 Product Code: EMA 21 CFR Section: 872. 3275 Applicant: 3M ESPE AG DENTAL PRODUCTS

510(k) Number: K032455 Product Code: EMA 21 CFR Section: 872.3275 Applicant: KURARAY MEDICAL INC.

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3-4. Device Description

PANAVIA SA CEMENT Automix is a dual-cure (light- and/or self-cure), radiopaque self-adhesive resin cement for porcelain, ceramic, composite resin and metal restorations. It is supplied in an automix delivery system which can mix equal amount of two components. It is intended for the following indications:

(1) Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
(2) Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
(3) Cementation of metal cores, resin cores, metal posts or glass fiber posts
1. It is classified into dental cement (21 CFR section 872,3275, Product code: EMA ) according to 21 CFR8872 since it is composed of various materials other than zinc oxide-eugenol.
1. 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:
- Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present

(This product contains the adhesive monomer. ISO 4049:2009 does not cover the polymer-based luting materials that have an adhesive component within the structure of the material. However, we tested referring to this standard.)

3-5. Substantial Equivalence Discussion

1) Intended uses

The INDICATIONS of the subject device were written up based on those of the predicate devices. Therefore, the intended purposes of the subject device are substantially the same as those of the predicate ones.

2) Chemical ingredients / Safety

All chemical ingredients of PANAVIA SA CEMENT Automix are the same as those of the predicate device, CLEARFIL SA CEMENT.

Regarding the prediente device, there have not heen any reported problems or recolls incording to the wost-market adverse event reporting requirements in U.S.

Therefore, we have concluded that the safety of the subject device can be guaranteed.

3) Effectiveness / Performance

PANAVIA SA CEMENT Automix complies with all requirements of ISO 4049: 2009 as polymer-based restorative materials.

And also, the bond strength of the subject device is equivalent to that of the predicate devices. Therefore, it can be said that its effectiveness has also been proved.

3-6. Biocompatibility

All the chemical ingredients of the subject device, PANAVIA SA CEMENT Automix, are the same as those of the predicate device, CLEARFIL SA CEMENT, as shown on the tables of "7-4 Chemical ingredients": in "Section 7: Substantial Equivalence Discussion".

Regarding the predicate devices, there have not been any reported problems or recalls according to the post- market adverse event reporting requirements in U.S.

Therefore, we have concluded that the biological safety of the subject device can be guaranteed.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle with three lines representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the perimeter of the circle.

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

Mr. Michio Takigawa Manager KURARAY MEDICAL Incorporation Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku Japan 100-0004

MAR 3 0 2012

Re: K120379

Trade/Device Name: PANAVIA SA CEMENT Automix Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 31, 2012 Received: February 8, 2012

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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Page 2 - Mr. Takigawa

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: PANAVIA SA CEMENT Automix

Indications for Use:

[1] Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
[2] Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
[3] Cementation of metal cores, resin cores, metal posts or glass fiber posts

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

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)

Susan Ranner
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devicess

510(k) Number: K120329

6-1

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.