Cementation of crowns, bridges, inlays and onlays made of conventional porcelain, ceramic, hybrid ceramics, composite resin or metal
Cementation of metal cores, resin cores, metal posts or glass-fiber posts

Device Description

CLEARFIL SA CEMENT is a dual-cure (light-and/or self-adhesive resin cement for conventional porcclain, ceramic, hybrid ceramics (e.g. ESTENIA C&B), composite resin and metal restorations. It is classified into dental cement (21 CFR section 872.3275, Product code: EMA ) according to 21 CFR § 872 since it is composed of various materials other than zinc oxide-eugenol. According to the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials", this 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

AI/ML Overview

Here's the analysis of the provided text regarding the acceptance criteria and study for the device:

Device: CLEARFIL SA CEMENT (Dental adhesive resin cement)
510(k) Number: K081583

This submission focuses on demonstrating substantial equivalence to predicate devices, rather than an independent clinical study to establish acceptance criteria for novel performance claims. Therefore, the "acceptance criteria" discussed here are primarily compliance with an existing standard and comparative performance to predicates.

Acceptance Criteria and Reported Device Performance

Criteria	Reported Device Performance
1. Compliance with ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials" (specifically for Class 3 materials: dual-cure)	Verified: The device has been "verified to comply with the requirements of the applicable FDA recognized consensus standard, ISO 4049: 2000." It is classified as Class 3 under this standard.
2. Chemical Ingredient Equivalence/Safety	Substantially Equivalent: "All the chemical ingredients of CLEARFIL SA CEMENT, the subject device, have been used in the predicate devices, PANAVIA F2.0 and CLEARFIL ESTHETIC CEMENT & DC BOND. It indicates that the safety of the applicant device is substantially equivalent to that of the predicate devices." (References tables in "Section 7: Substantial Equivalence Discussion")
3. Effectiveness/Performance Equivalence to Predicate (MAXCEM) based on ISO 4049: 2000	Effective as well as the predicate: "As to comparison with the predicate device, MAXCEM, according to ISO 4049; 2000, it was proved that both the subject one and the predicate one complied with ISO 4049: 2000 and the subject one should be effective as well as the predicate one." This implies comparative testing against MAXCEM, although specific numerical performance results are not provided in this summary, only the conclusion of compliance and equivalence.
4. Intended Uses Equivalence	Equivalent: "It is intended to be used for the indications listed in the left hand column of the table of "Section 5: Executive Summary, Table 5" that are equivalent to the predicate devices, PANAVIA F2.0 and CLEARFIL ESTHETIC CEMENT & DC BOND." (Specific indications are listed in the "Indications for Use" section of the 510(k) – e.g., cementation of crowns, bridges, inlays, onlays, metal cores, resin cores, metal posts, glass-fiber posts.)
5. Biocompatibility Equivalence	Substantially Equivalent: "All the chemical ingredients of CLEARFIL SA CEMENT, the subject device, have been used in the predicate devices... From those tables [on chemical ingredients], it can be said that the safety of the subject device is substantially equivalent to the predicate devices."

Study Information:

Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for specific tests within ISO 4049: 2000 or for the comparative effectiveness study against MAXCEM.
- Data provenance is not specified (e.g., country of origin, retrospective/prospective). Dental material testing standards like ISO 4049 typically involve in vitro laboratory tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the studies described appear to be in vitro laboratory tests (compliance with ISO 4049) rather than studies requiring expert interpretation of clinical data or images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable for in vitro laboratory tests.
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 device is a dental cement, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This isn't an algorithm; it's a dental material.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For compliance with ISO 4049, the "ground truth" would be established by the measurement protocols and physical properties defined within the ISO standard itself, measured by laboratory equipment. For example, mechanical strength, film thickness, water sorption, solubility, etc.
The sample size for the training set:
- Not applicable. This is a physical product, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable. (Same as above).

Summary of the "Study":

The "study" referenced in the 510(k) summary is primarily focused on demonstrating compliance with the international standard ISO 4049: 2000 ("Dentistry - Polymer-based filling, restorative and luting materials") for the physical and chemical properties of the dental cement. Additionally, a comparative evaluation against a predicate device (MAXCEM) was performed to show that both met the ISO standard, leading to the conclusion that the subject device is "effective as well as the predicate one." The primary evidence for substantial equivalence lies in the chemical composition being identical to or derived from predicate devices, and the material's physical properties meeting an established performance standard. No clinical trials or human-reader studies are mentioned or evidently required for this type of device and submission.

Summary

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510(k) Summary

JUL 2 8 2008

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

Name
Address
Contact person
Contact person in U.S.

KURARAY MEDICAL INC.

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

CLEARFIL SA CEMENT

Dental adhesive resin cement

Dental cement

510(k) Number:

21 CFR Section:

Product Code:

Applicant:

Koji Nishida 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

(21 CFR section 872.3275. Product code: EMA)

K032455

872.3275

EMA

3-2. Name of Device

Trade / Proprietary name
Classification name
Common name

3-3. Predicate device

MAXCEM
PANAVIA F 2.0

Applicant: 2) CLEARFIL ESTHETIC CEMENT & DC BOND

510(k) Number: K062410 Product Code: EMA

21 CFR Section: 872. 3275 KURARAY MEDICAL INC.

KURARAY MEDICAL INC.

510(k) Number: Product Code: 21 CFR Section: Applicant:

K041474 EMA 872. 3275 SYBRON DENTAL SPECIALTIES INC.

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3-4. Device Description

1. CLEARFIL SA CEMENT is a dual-cure (light-and/or self-adhesive resin cement for conventional porcclain, ceramic, hybrid ceramics (e.g. ESTENIA C&B), composite resin and metal restorations.
1. It is classified into dental cement (21 CFR section 872.3275, Product code: EMA ) according to 21 CFR § 872 since it is composed of various materials other than zinc oxide-eugenol.
1. According to the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials", this 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

3-5. Substantial Equivalence Discussion

1) Intended uses

It is intended to be used for the indications listed in the left hand column of the table of "Section 5: Executive Summary, Table 5" that are equivalent to the predicate devices, PANAVIA F2.0 and CLEARFIL ESTHETIC CEMENT & DC BOND.

2) Chemical ingredients / Safety

All the chemical ingredients of CLEARFIL SA CEMENT, the subject device, have been used in the predicate devices, PANAVIA F2.0 and CLEARFIL ESTHETIC CEMENT & DC BOND. It indicates that the safety of the applicant device is substantially equivalent to that of the predicate devices.

3) Effectiveness / Performance

CLEARFIL SA CEMENT, the subject device, has been verified to comply with the requirements of the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials". As to comparison with the predicate device, MAXCEM, according to ISO 4049; 2000, it was proved that both the subject one and the predicate one complied with ISO 4049: 2000 and the subject one should be effective as well as the predicate one,

3-6. Biocompatibility

All the chemical ingredients of CLEARFIL SA CEMENT, the subject device, have been used in the predicate devices as shown on the tables of "Section 7: Substantial Equivalence Discussion, Table: 7-2, 7-3, 7-4" where all the chemical ingredients of the subject device are listed in the left hand column and the abbreviated names of the predicate devices which contain the chemical component are listed in the right hand. From those tables, it can be said that the safety of the subject device is substantially equivalent to the predicate devices.

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, depicted with flowing lines to represent its wings and body. The eagle faces to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2008

Kuraray Medical, Incorporated C/O Mr. Koji Nishida General Manager Kuraray America, Incorporated 600 Lexington Avenuc, 26th Floor New York, New York 10022

Re: K081583

Trade/Device Name: CLEARFIL™ SA CEMENT Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA, KLE Dated: June 3, 2008 Received: June 12, 2008

Dear Mr. Nishida:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Nishida

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D. 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

K 68158 3 510(k) Number (if known):

Device Name: _CLEARFIL SA CEMENT

Indications for Use:

1. Cementation of crowns, bridges, inlays and onlays made of conventional porcelain, ceramic, hybrid ceramics, composite resin or metal
1. Cementation of metal cores, resin cores, metal posts or glass-fiber posts

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)

Susan Reaser

Division Sign-Off) Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices

10(k) Number:

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.