(27 days)
CLEARFIL ST OPAQUER is indicated for the following applications:
- Masking of metal during intraoral repair of porcelain fused-to-metal crowns.
- Masking of metal in restoration of post and core crowns.
- Lightening of stained or discolored teeth in porcelain or composite veneer restorations.
- Masking of pulp capping materials.
CLEARFIL ST OPAQUER is classified into the Tooth Shade Resin Material, CFR 21 Section 872.3690. because it is a device composed of materials such as bisphenol-A glycidylmethacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.
This document is related to a 510(k) submission for a dental material, CLEARFIL ST OPAQUER. The submission is not for a new device, but rather a change in manufacturer (from Kuraray Co., Ltd. to Kuraray Medical Inc.) for an already cleared device. Therefore, a study demonstrating the device meets acceptance criteria is not provided or required. The core of this submission is to assert "substantial equivalence" to a predicate device, meaning it has the same intended use, technological characteristics, and safety profile as the device already on the market.
Based on the provided document, there is no study detailed that proves the device meets specific acceptance criteria in the way one would for a novel medical device requiring performance testing.
The document states:
- "This device is essentially the same as CLEARFIL ST OPAQUER manufactured by Kuraray Co., Ltd. (K001913). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL ST OPAQUER."
This statement is the central "proof" for this 510(k) submission. The acceptance criteria are implicitly met because the device is identical to a device already cleared by the FDA (predicate device K001913).
Therefore, most of the requested information regarding study details (sample sizes, experts, adjudication, MRMC, standalone performance, ground truth establishment, training set) is not applicable to this type of regulatory submission.
However, I can extract the acceptance criteria (intended uses) and explain the "proof" presented in this specific context:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Intended Uses) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| 1) Masking of metal during intraoral repair of porcelain fused-to-metal crowns. | "This device is essentially the same as CLEARFIL ST OPAQUER manufactured by Kuraray Co., Ltd. (K001913). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL ST OPAQUER." |
| 2) Masking of metal in restoration of post and core crowns. | (Same as above) |
| 3) Lightening of stained or discolored teeth in porcelain or composite veneer restorations. | (Same as above) |
| 4) Masking of pulp capping materials. | (Same as above) |
Explanation of "Proof": The core argument is based on substantial equivalence. The new applicant (Kuraray Medical Inc.) asserts that their device is identical in composition and function to a predicate device (CLEARFIL ST OPAQUER from Kuraray Co., Ltd. K001913) that has already been cleared by the FDA for these specific indications. No new performance data is presented because the device itself is not new; only the manufacturer's name/address is being updated in the regulatory filing.
2. Sample size used for the test set and the data provenance:
- Not applicable. No new performance study was conducted. The "test set" is the predicate device's existing performance, implicitly accepted by the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new performance study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new performance study was conducted.
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:
- Not applicable. This is a dental material, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a dental material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. Performance data is not part of this specific 510(k) summary because it's a manufacturer change, not a new device. The implicit ground truth for the predicate device would have been established through prior testing and clinical use, but those details are not in this document.
8. The sample size for the training set:
- Not applicable. This is a dental material, not an AI-powered device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a dental material.
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DICAL INC. JRARAY MEC ental Material Department
Image /page/0/Picture/2 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" with a unique design. The word "KURARAY" is printed in a bold, sans-serif font below the letter "K".
1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN +81-6-348-2603 Facsimile: +81-6-348-2552
Image /page/0/Picture/4 description: The image shows a handwritten sequence of characters, which appears to be a combination of letters and numbers. The sequence reads 'K012704'. The characters are written in a bold, somewhat stylized manner, with varying stroke thicknesses. The handwriting is clear and legible against the plain background.
SEP 1 0 2001
510(k) SUMMARY
| 1. Submitter | ||
|---|---|---|
| 1) Name | KURARAY MEDICAL INC. | |
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan | |
| 3) Contact person | Koji NishidaDENTAL MATERIAL DEPARTMENT | |
| 4) Date | August 9, 2001 | |
| 5) Contact person in U.S.A. | Masaya Sasaki30th Fl. Metlife Building, 200 Park Avenue, New York,NY 10166Telephone : (212)-986-22301-(800)-879-1676Facsimile : (212)-867-3543 |
2. Name of Device
| 1) Proprietary Name | CLEARFIL ST OPAQUER |
|---|---|
| 2) Classification Name | Tooth Shade resin Material (21CFR 872.3690) |
| 3) Common/Usual Name | Dental composite resin for masking |
3. Predicate device:
Kuraray Co., Ltd. will transfer the medical device business and the relevant functions including manufacturing facilities to its subsidiary company named Kuraray Medical Inc. on The aim of 510(k) submission is to alter the name and address of October 1st 2001. manufacturer, and not to intend other changes.
The predicate device is as follow.
- CLEARFIL ST OPAQUER by Kuraray Co., Ltd. (K001913) 1.
-
- Description for the premarket notification
CLEARFIL ST OPAQUER is classified into the Tooth Shade Resin Material, CFR 21 Section bisphenol-A because it is a device composed of materials such as 872.3690. glycidylmethacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.
5. Statement of the intended use
The intended uses of this device are as follows. They are completely the same as CLEARFIL ST OPAQUER manufactured by Kuraray Co., Ltd. (K001913).
-
- Masking of metal during intraoral repair of porcelain fused-to-metal crowns.
-
- Masking of metal in restoration of post and core crowns.
-
Lightening of stained or discolored teeth in porcelain or composite veneer restorations.
-
Masking of pulp capping materials.
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6. Statement of the technological characteristics and safety
This device is essentially the same as CLEARFIL ST OPAQUER manufactured by Kuraray Co., Ltd. (K001913). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL ST OPAQUER.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2001
Kuraray Medical Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30th Floor Metlife Building 200 Park Avenue New York, New York 10166
Re: K012704
Trade/Device Name: Clearfil ST Opaquer Regulation Number: 872.3690 Regulation Name: Dental Composite Resin For Masking Regulatory Class: II Product Code: EBF Dated: August 9, 2001 Received: August 14, 2001
Dear Ms. Sasaki:
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.
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
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of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal cannotes as requirements, including, but not limited to: registration Tour must comply with and are labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF RT rat 807), labeling (25) regulation (21 CFR Part 820); and if requirements as Sectionic product radiation control provisions (section 531-542 of the Act; 21): CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 510(k) I mis letter will and w your of substantial equivalence of your device of your device to a premitset notification. - The Pere 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 If you dosire specific and for in vitro diagnostic devices), please contact the Office of and additionally 0091194-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the notification (21011 16 0079). Outsi good Small Manufacturers, International and Consumer Act may be obtained from the Dristen (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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[CLEARFIL ST OPAQUER , Kuraray Medical Inc.]
Image /page/4/Picture/1 description: The image contains a sequence of characters that appear to be handwritten. The characters are K012704. The characters are written in a bold, sans-serif font. The image is a close-up of the characters, and the background is white.
510(k) Number (if known): KD12704
Device Name: CLEARFIL ST OPAQUER
Indications for Use
CLEARFIL ST OPAQUER is indicated for the following applications:
- Masking of metal during intraoral repair of porcelain fused-to-metal crowns. 1)
- Masking of metal in restoration of post and core crowns. 2)
- Lightening of stained or discolored teeth in porcelain or composite veneer restorations. 3)
- Masking of pulp capping materials. 4)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use__
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Runne
(Division Sign-Off) (Division Sign-On))
Division of Dental, Infection Control, Division of General Hospital D 515(k) Number -
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.