(35 days)
Not Found
No
The device description and intended use clearly define it as a resin tooth bonding agent for dental restorations, with no mention of AI or ML capabilities.
No.
The device description clearly states it is a "Resin tooth bonding agent" used to improve retention of dental restorations, which is not a therapeutic function.
No
Explanation: The Intended Use and Device Description clearly state that this device is a bonding agent used to improve retention of dental restorations, not for diagnosing any condition.
No
The device description explicitly states it is composed of materials like dimethacrylate monomers, indicating it 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/Indications for Use: The intended use is for bonding composite resin and amalgam restorations to dentin and enamel. This is a direct application to the tooth for restorative purposes, not for testing or diagnosing a condition in vitro (outside the body).
- Device Description: The description clearly states it's a "Resin tooth bonding agent" intended to be painted on the interior of a prepared cavity to improve retention of a restoration. This aligns with a dental restorative material, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
Therefore, based on the provided text, CLEARFIL PHOTO BOND is a dental device used for bonding restorations, not an IVD.
N/A
Intended Use / Indications for Use
CLEAFIL PHOTO BOND is indicated for the following applications:
- A dentin and enamel bonding system for composite resin restoration 1)
-
- A dentin and enamel bonding system for amalgam restoration
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
CLEARFIL PHOTO BOND is classified into Resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling. Normally composite resins and amalgams are used as filling material for this purpose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
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
. . . . . .
Image /page/0/Picture/1 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" that is formed by a combination of straight and angled lines. Below the symbol is the word "KURARAY" in a bold, sans-serif font. The entire logo is set against a black background.
Dental Material Department 2-39, 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN : +81-6-348-2603 Facsimile: +81-6-348-2552
SEP = 4 2001
510(k) SUMMARY
DICAL INC.
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 | July 23, 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 PHOTO BOND |
---|---|
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 PHOTO BOND by Kuraray Co., Ltd. (K943165)
4. Description for the premarket notification
CLEARFIL PHOTO BOND is classified into Resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling. Normally composite resins and amalgams are used as filling material for this purpose.
1
5. Statement of the intended use
The intended uses of this device are as follows. They are completely the same as CLEARFIL PHOTO BOND manufactured by Kuraray Co., Ltd. (K943165).
- A dentin and enamel bonding system for composite resin restoration 1)
- A dentin and enamel bonding system for amalgam restoration 2)
6. Statement of the technological characteristics and safety
This device is essentially the same as CLEARFIL PHOTO BOND manufactured by Kuraray Co., Therefore the technological characteristics, chemical ingredients and safety of td. (K943165). this device are completely the same as CLEARFIL PHOTO BOND.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is an emblem that appears to be an abstract representation of an eagle or other bird, with three stylized wing shapes. The emblem is positioned in the center of the circle.
SEP - 4 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 : K012432 Rolaisa
Trade/Device Name: Modification To Clearfil Photo Bond 872.3200 Requlation Number: Regulatory Class: II Product Code: KLE Dated: July 23, 2001 Received: July 31, 2001
Dear Ms. Sasaki:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major be basjood of bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
3
Page 2 - Ms. Sasaki
This letter will allow you to begin marketing your device as This lecter will allow you comes motification. The FDA described in your 510 (x) premaince of your device to a legally marketed predicate device results in a classification for your marketed predicate device robadevice to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpccribed and additionally 809.10 for in regulacion (21 crk Fare ) , please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on Compriamet at (501) devertising 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 premation on your responsibilities under the Act may be Intoimation on Jour vision of Small Manufacturers, obtained from the Division Assistance at its toll-free number Incernational and Combames - 6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Timothy A. Ulatowski
Ulatowski A. Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
[CLEARFIL PHOTO BOND, Kuraray Medical Inc.]
Image /page/4/Picture/1 description: The image shows a sequence of characters and numbers. The sequence starts with the letter 'K', followed by the number '0', then '12432'. The characters and numbers are written in a bold, handwritten style, giving them a distinct and somewhat informal appearance.
(012 137 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: CLEARFIL PHOTO BOND
Indications for Use
CLEAFIL PHOTO BOND is indicated for the following applications:
- A dentin and enamel bonding system for composite resin restoration 1)
-
- A dentin and enamel bonding system for amalgam restoration
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Part 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Susan Ranny
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number