(95 days)
No
The device description and the lack of mentions of AI, ML, or related concepts strongly suggest this is a traditional dental restorative material without AI/ML components.
No
This device is a dental restorative material used for core build-up, which is a structural repair and not a therapeutic function. Therapeutic devices are typically used to treat a disease, injury, or condition.
No
Explanation: The device is described as a dental composite resin restorative material used for core build-up of teeth. Its intended use is to restore or repair the tooth structure, which is a treatment function, not a diagnostic one. There is no mention of it being used to identify or analyze a condition.
No
The device description clearly states it is a "dental composite resin restorative material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Core build-up of vital or non-vital tooth." This is a direct treatment or restoration of a tooth, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is described as a "dental composite resin restorative material." This is a material used for physical restoration, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a dental restorative material used directly on the tooth for structural purposes.
N/A
Intended Use / Indications for Use
- Core build up of vital or non vital tooth
Product codes
EBF
Device Description
This device is a dental composite resin restorative material. The composite resin is substantially equivalent to CLEARFIL PHOTO CORE (K012705) as the chemical composition, ingredients and intended use are the same as those of the predicate device. Also, this device is different from CLEARFIL PHOTO CORE (K012705) in that it is filled in disposable tips, but the disposable tips are substantially cquivalent to those that are used in CLEARFIL AP-X PLT (K012705).
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)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image is a black and white logo. The logo features a stylized letter "K" with a geometric design. The letter is formed by a combination of straight lines and sharp angles, creating a modern and abstract look. The logo has a distressed or textured appearance, with small specks and imperfections scattered throughout, giving it a vintage or worn feel.
KURARAY MEDICAL INC.
Quality Assurance Department Kuraray Nihonbashi Bldg. 3-1-6 Nihonbashi, Chuo-ku, Tokyo 103-82541 Phone : +81-(0)3-3277-6933 Facsimile: +81-(0)3-3277-6577
MAR 2 6 2004
510(k) SUMMARY
| 1. Submitter | |
|---|---|
| 1) Name | KURARAY MEDICAL INC. |
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) 1. Contact person | Masaya Sasaki |
| Dental Material Division, Kuraray Medical Inc. |
| 2. Contact person in U.S.A. | Satoshi Yamaguchi |
|---|---|
| Kuraray America Inc. | |
| 101 East 52nd Street, 26th Floor | |
| New York, NY 10022 | |
| Telephone: (212)-986-2230 (Ext. 115) | |
| 1-(800)-879-1676 | |
| Facsimile: (212)-867-3543 | |
| 4) Date | December 19, 2003 |
2. Name of Device
| 1) Proprietary Name | CLEARFIL PHOTO CORE PLT |
|---|---|
| 2) Classification Name | Tooth shade resin material (21CFR 872.3690) |
| 3) Common/Usual Name | Light-cured Composite Resin for Core Build Up |
3. Predicate device
The predicate device is as follow;
- CLEARFIL PHOTO CORE manufactured by Kuraray Medical Inc. 1. (K012705)
- CLEARFIL AP-X PLT manufactured by Kuraray Medical Inc. ১। (K023002)
-
- Description for the premarket notification
This product is classified into Tooth shade Resin Material, 21CFR Section 872,3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth.
-
- Statement of the intended use
The intended use of this device is as follows. It is the same as that of CLEARFIL PHOTO CORE (K012705).
- Statement of the intended use
-
- Core build up of vital or non vital tooth
-
- Statement of the technological characteristics and safety
This device is a dental composite resin restorative material. The composite resin is substantially equivalent to CLEARFIL PHOTO CORE (K012705) as the chemical composition, ingredients and intended use are the same as those of the predicate device. Also, this device is different from CLEARFIL PHOTO CORE (K012705) in that it is filled in disposable tips, but the disposable tips are substantially cquivalent to those that are used in CLEARFIL AP-X PLT (K012705).
Therefore this device is substantially equivalent in safety and technological characteristics as the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
MAR 2 6 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kuraray Medical Incorporated C/O Mr. Satoshi Yamaguchi Kuraray America, Incorporated 101 East 52nd Street, 26td Floor New York, New York 10022
Re: K033970
Trade/Device Name: Clearfil Photo Core PLT Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 19, 2003 Received: December 29, 2003
Dear Mr. Yamaguchi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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.
2
Page 2 - Mr. Yamaguchi
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advised that 22 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 promation hourseline 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), n you dontact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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3
Indications for Use
510(k) Number (if known): K033970
Device Name: Clearfil Photo Core PLT
Indications For Use: 1) Core bulld-up of vital or non-vital tooth
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suen Riinger
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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number __