(30 days)
Not Found
No
The device description and intended use focus on the material composition and application for dental repairs, with no mention of AI or ML capabilities.
No
The device is a resin tooth bonding agent used for intraoral repairs of fractured dental restorations, which is a restorative rather than therapeutic application.
No
Explanation: The device, CLEARFIL REPAIR, is described as a resin tooth bonding agent intended to improve retention of restorative materials for intraoral repairs. Its function is to facilitate repair, not to diagnose a condition.
No
The device description explicitly states it is composed of materials like dimethacrylate monomers, which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for intraoral repairs of dental restorations (crowns, bridges, inlays, onlays). This is a direct application within the mouth for structural repair.
- Device Description: The device is classified as a "resin tooth bonding agent" and is intended to be "painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials." This further reinforces its use in direct dental procedures.
- 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 screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body for restorative purposes.
N/A
Intended Use / Indications for Use
The intended uses of this device are as follows. They are completely the same as CLEARFIL REPAIR manufactured by Kuraray Co., Ltd. (K001914).
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- Intraoral repairs of fractured porcelain or composite facing crowns/bridges
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- Intraoral repairs of fractured all ceramics restorations
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- Intraoral repairs of fractured porcelain and composite inlays/onlays
CLEARFIL REPAIR is indicated for the following applications:
- Intraoral repairs of fractured porcelain or composite facing crowns/bridges.
- Intraoral repairs of fractured all ceramics restorations.
- Intraoral repairs of fractured porcelain and composite inlays/onlays.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
CLEARFIL REPAIR is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
KURARAY MEDICAL INC.
Image /page/0/Picture/2 description: The image is a black and white logo for Kuraray. The logo features a stylized letter 'K' formed by thick lines, with a smaller, geometric shape nested within it. Below the symbol, the word 'KURARAY' is printed in block letters.
Dental Material Department 12-39, 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN · +81-6-348-2603 Phone Facsimile: +81-6-348-2552
KO12729
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 REPAIR |
|---|---|
| 2) Classification Name | Resin tooth bonding agent (21CFR 872.3200) |
| 3) Common/Usual Name | Resin-based dental adhesive system |
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 October 1st 2001. The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes.
The predicate device is as follow.
- CLEARFIL REPAIR by Kuraray Co., Ltd. (K001914) 1.
-
- Description for the premarket notification
CLEARFIL REPAIR is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials.
5. Statement of the intended use
The intended uses of this device are as follows. They are completely the same as CLEARFIL REPAIR manufactured by Kuraray Co., Ltd. (K001914).
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- Intraoral repairs of fractured porcelain or composite facing crowns/bridges
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- Intraoral repairs of fractured all ceramics restorations
- Intraoral repairs of fractured porcelain and composite inlays/onlays
1
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- Statement of the technological characteristics and safety
This device is essentially the same as CLEARFIL REPAIR manufactured by Kuraray Co., Ltd. Therefore the technological characteristics, chemical ingredients and safety of this (K001914). device are completely the same as CLEARFIL REPAIR.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three overlapping human profiles.
SEP 1 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kuraray Medical Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30th Floor Metlife Building 200 Park Avenue New York, New York 10166
Re: K012729
Trade/Device Name: Clearfil Repair Regulation Number: 872.3200 Regulation Name: Dental Light-Cured Repair Kit Regulatory Class: II Product Code: KLE 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
3
Page 2 - Ms. Sasaki
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 r ou intilet confirst war and 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 (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) 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
A. Ulatowski Timotl Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
4
[CLEARFIL REPAIR, Kuraray Medical Inc.]
Image /page/4/Picture/1 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the digit '0', then the digit '1', then the digit '2', then the digit '7', then the digit '2', and ends with the digit '9'. The characters are written in a clear, sans-serif font.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CLEARFIL REPAIR
Indications for Use
CLEARFIL REPAIR is indicated for the following applications:
-
Intraoral repairs of fractured porcelain or composite facing crowns/bridges.
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Intraoral repairs of fractured all ceramics restorations.
-
Intraoral repairs of fractured porcelain and composite inlays/onlays.
(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 Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number .