SURFACE COAT is a single-component, light-cure resin glaze material that provides a clear and smooth surface, consisting of a multi-functional acrylate monomer that provides excellent durability and may reduce or even eliminate the need for manual polishing. SURFACE COAT has virtually no surface oxygen inhibition layer.

AI/ML Overview

The provided 510(k) summary for K063228 (SURFACE COAT) does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) premarket notification, which largely focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria in the manner you've outlined for clinical or diagnostic devices.

However, based on the available information, I can extract and infer some aspects:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Since there is no applicable FDA's recognized standard or international standard concerning performance of this type of device, certain specifications are designed for SURFACE COAT, the applicant device, and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent to the predicate devices in terms of the effectiveness and performance."

This indicates that internal specifications were used, but these specific specifications and their corresponding performance metrics are not detailed in this 510(k) summary. It only mentions that the device was tested accordingly and validated against predicate devices for effectiveness and performance.

Acceptance Criterion (Type & Metric)	Reported Device Performance
Not Specified	Not Specified
(Likely internal specifications related to properties like durability, surface smoothness, oxygen inhibition layer characteristics relevant to a resin glaze material)	(Performed comparably or superiorly to predicate devices based on unspecified internal tests)

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

Sample size for test set: Not specified.
Data provenance: Not specified. Since it's a materials science submission, it's highly likely to be laboratory/bench testing data rather than patient data from a specific country, and thus, "retrospective or prospective" would not apply in the typical clinical sense.

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

This type of information (experts establishing ground truth) is typical for clinical studies involving diagnosis or interpretation. For a dental material, "ground truth" would likely be established through objective laboratory measurements and material science standards/tests, not expert consensus in the diagnostic sense.
Not applicable/Not specified.

4. Adjudication Method for the Test Set

Not applicable/Not specified for this type of material performance testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for diagnostic devices involving human readers interpreting images or data. It is not relevant for a dental resin glaze material.

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

Not applicable. This device is a material, not a software algorithm.

7. The Type of Ground Truth Used

For a material like "SURFACE COAT," the "ground truth" would be established by the physical and chemical properties of the material as measured by standardized laboratory methods (e.g., tests for hardness, wear resistance, bond strength, surface smoothness, oxygen inhibition layer thickness).
The document implies these were internal "specifications" and comparisons to predicate devices for "effectiveness and performance."

8. The Sample Size for the Training Set

Not applicable/Not specified. The concept of a "training set" is usually for machine learning algorithms. For material development, various formulations and batches might be tested during R&D, but this isn't typically referred to as a "training set" in the context of regulatory submissions for materials.

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

Not applicable/Not specified.

Summary of Study Information (as inferable from the document):

The submission relies on demonstrating substantial equivalence to predicate devices (BISCOVER LIQUID POLISH, BISCOVER LV, etc.) rather than a full de novo performance study against explicit acceptance criteria.

The study performed was a comparison of the SURFACE COAT's effectiveness and performance characteristics against those of the predicate devices. The exact nature of these tests (e.g., specific mechanical properties tested, methods used) and their quantitative results are not disclosed in this summary. The manufacturer states that "certain specifications are designed for SURFACE COAT...and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent." This implies bench testing to show similar or superior material properties relative to the predicates.

In essence, the "study" for this 510(k) demonstrated that the new device performs sufficiently similar to already approved devices, making it substantially equivalent, without needing to define new, explicit clinical acceptance criteria in the format you requested.

Summary

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K063228

DEC - 8 2006

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October 24, 2006 Date:

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510(k) Summary

510(k) owner (submitter)

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1) Name	KURARAY MEDICAL INC.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
3) Contact person	Michio TakigawaQuality Assurance Department
4) Contact person in U.S.	Koji NishidaKURARAY AMERICA, INC.600 Lexington Avenue, 26th FloorNew York, NY 10022Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676Fax: (212)-867-3543
2. Name of Device
1) Trade / Proprietary name	SURFACE COAT
2) Classification name	Coating, Filling Material, Resin(21 CFR section 872.3310. Product code: EBD)
3) Common name	Resin glaze material
3. Predicate device
1) BISCOVER LIQUID POLISH	510(k) Number:Product Code:21 CFR Section:Applicant:	K030354EBD872.3310BISCO, INC.
2) BISCOVER LV	510(k) Number:Product Code:21 CFR Section:Applicant:	K043168EBD872.3310BISCO, INC.
3) C&B METABOND	510(k) Number:Product Code:21 CFR Section:Applicant:	K960464EMA872.3275PARKELL, INC.

4) CHROMA ZONE COLOR STAIN	510(k) Number:Product Code:21 CFR Section:Applicant:	K012737EBF872.3690KURARAY MEDICAL, INC.
5) PANAVIA F 2.0	510(k) Number:Product Code:21 CFR Section:Applicant:	K032455EMA872.3275KURARAY MEDICAL, INC.

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KURARAY MEDICAL INC.

Quality Assurance Department

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1. Description of device
  SURFACE COAT is a single-component, light-cure resin glaze material that provides a clear and smooth surface, consisting of a multi-functional acrylate monomer that provides excellent durability and may reduce or even eliminate the need for manual polishing. SURFACE COAT has virtually no surface oxygen inhibition layer.

Intended use

SURFACE COAT, the applicant device, is used to glaze/polish following restorations:

Direct and indirect composite resins
Acrylic provisional crowns and bridges
Acrylic appliances
Glass ionomers and resin-modified glass ionomers

SURFACE COAT shares the same intended use as those included in the intended uses of BISCOVER LIQUID POLISH and BISCOVER LV, the predicate devices. SURFACE COAT is indicated for more limited uses than the predicate devices, as it is not used for enamel.

1. Substantial equivalence
  The safety and effectiveness of SURFACE COAT, the applicant device, are equivalent to the predicate devices.
1. Effectiveness / Performance
  Since there is no applicable FDA's recognized standard or international standard concerning performance of this type of device, certain specifications are designed for SURFACE COAT, the applicant device, and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent to the predicate devices in terms of the effectiveness and performance.
1. Safety
  SURFACE COAT, the applicant device, contains chemical ingredients which have been used in the predicate devices and copes with any possible risk in a similar manner as the predicate devices suggesting the safety of the applicant device is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2006

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

Re: K063228

Trade/Device Name: Surface Coat Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: October 24, 2006 Received: October 31, 2006

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. Koji 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 (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.

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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,

Smitte y. Michael Davis.

Chiu S. Lin, PhD 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

06 3228 510(k) Number (if known):

Device Name: __SURFACE COAT

Indications for Use:

SURFACE COAT is used to glaze/polish following restorations:

Direct and indirect composite resins
Acrylic provisional crowns and bridges
Acrylic appliances
Glass ionomers and resin-modified glass ionomers

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X 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 Dunne

ි වෙන්වන A. Dona

KD630235

Regulation Number and Section

§ 872.3310 Coating material for resin fillings.

(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.