(27 days)
Not Found
No
The summary describes a dental restorative material and does not mention any AI or ML capabilities.
No
The device is described as a tooth shade resin material for masking and restoring teeth, not for treating diseases or conditions. Its classification also points to it being a restorative material.
No
Explanation: The device is described as a "Tooth Shade Resin Material" used for masking and lightening applications. Its intended uses (masking metal, lightening discolored teeth, masking pulp capping materials) are all restorative or aesthetic in nature, not diagnostic. A diagnostic device would typically involve identifying or determining the presence, nature, or cause of a disease or condition.
No
The device description clearly states it is a "Tooth Shade Resin Material" composed of physical materials like Bis-GMA, which are used to restore teeth. This indicates a physical, material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental restoration and masking within the mouth (intraoral). This involves direct application to teeth and dental structures.
- Device Description: The device is classified as a "Tooth Shade Resin Material" and is described as being composed of materials intended to restore defects in teeth. This aligns with a dental restorative material, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (within the body) application in a dental setting.
N/A
Intended Use / Indications for Use
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- Masking of metal during intraoral repair of porcelain fused-to-metal crowns.
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- Masking of metal in restoration of post and core crowns.
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- Lightening of stained or discolored teeth in porcelain or composite veneer restorations.
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- Masking of pulp capping materials.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Nishida | |
| DENTAL MATERIAL DEPARTMENT | ||
| 4) Date | August 9, 2001 | |
| 5) Contact person in U.S.A. | Masaya Sasaki | |
| 30th Fl. Metlife Building, 200 Park Avenue, New York, | ||
| NY 10166 | ||
| Telephone : (212)-986-2230 | ||
| 1-(800)-879-1676 | ||
| Facsimile : (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.
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- 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).
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- Masking of metal during intraoral repair of porcelain fused-to-metal crowns.
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- Masking of metal in restoration of post and core crowns.
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Lightening of stained or discolored teeth in porcelain or composite veneer restorations.
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Masking of pulp capping materials.
1
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.
2
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 -