(28 days)
Not Found
No
The device description and intended use clearly state it is a light-curing composite material for core build-up, with no mention of AI or ML.
No
The device is described as a "Tooth shade resin material" for "Restoration where a light-curing composite for core build-up is required," which typically refers to dental filling or restoration material, not a therapeutic device designed to cure or treat a disease or medical condition.
No
Explanation: The device is described as a "Restoration where a light-curing composite for core build-up is required" and "a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to be used for core build-up." This indicates it is a therapeutic or restorative device, not one used for diagnosis.
No
The device description explicitly states it is composed of materials like bisphenol A glycidylmethacrylate (Bis-GMA), which are physical components, 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 for "Restoration where a light-curing composite for core build-up is required." This describes a dental restorative procedure performed directly on a patient's tooth.
- Device Description: The device is classified as "Tooth shade resin material" and is intended for "core build-up." This further confirms its use in a dental procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with bodily specimens.
Therefore, based on the provided text, CLEARFIL PHOTO CORE is a dental restorative material, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CLEARFIL PHOTO CORE is indicated for the following applications: 1) Restoration where a light-curing composite for core build-up is required.
Product codes
EBF
Device Description
This product is classified into Tooth shade resin material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to be used for core build-up.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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" with a geometric design. The word "KURARAY" is printed in a simple sans-serif font below the symbol.
Dental Materia| Department 12-39, 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN : +81-6-348-2603 Facsimile: +81-6-348-2552
SEP 1 1 2001
510(k) SUMMARY
-
- Submitter
-
- Name
-
- Address
-
- Contact person
-
- Date
-
- Contact person in U.S.A.
KURARAY MEDICAL INC. 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan Koji Nishida DENTAL MATERIAL DEPARTMENT August 9, 2001 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
3. Name of Device
| 1) Proprietary Name |
|---|
| 2) Classification Name |
| 3) Common/Usual Name |
CLEARFIL PHOTO CORE Tooth shade resin material Light-cured Composite Resin for Core Build Up
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 PHOTO CORE by Kuraray Co., Ltd. (K882006) 1.
4. Description for the premarket notification
This product is classified into Tooth shade resin material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to be used for core build-up.
5. Statement of the intended use
The intended use of this device is as follow. That is completely the same as CLEARFIL PHOTO CORE manufactured by Kuraray Co., Ltd. (K882006).
- Restoration where a light-curing composite for core build-up is required.
1
-
- Statement of the technological characteristics and safety
This device is essentially the same as CLEARFIL PHOTO CORE manufactured by Kuraray Co., Ltd. (K882006). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL PHOTO CORE.
- Statement of the technological characteristics and safety
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings.
SEP 1 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kuraray Medical Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30# Floor Metlife Building 200 Park Avenue New York, New York 10166
Re: K012705
Trade/Device Name: Clearsil Photo Core Regulation Number: 872.3690 Regulation Name: Light-Cured Composite Resin for Core Build Up 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 (1 1 1) 1) vice 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
3
Page 2 - Ms. Sasaki
mean that FDA has made a determination that your device complies with other requirements modified in any Federal statutes and regulations administered by other Federal agencies. or the For all , I vith all the Act's requirements, including, but not limited to: registration r our indisting (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 roquirements as bectronic 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) Fins fection with cation. The FDA finding of substantial equivalence of your device to a promation noutheanced.
Iegally 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,
Tim A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
4
[CLEARFIL PHOTO CORE, Kuraray Medical Inc.]
510(k) Number (if known): K012705
Device Name: CLEARFIL PHOTO CORE
Indications for Use
CLEARFIL PHOTO CORE is indicated for the following applications: Restoration where a light-curing composite for core build-up is required. 1)
(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)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 1272705
14 of 15