(31 days)
Not Found
No
The document describes a resin-based pit and fissure sealant and does not mention any AI or ML components or functionalities.
Yes
The device is a pit and fissure sealant, which is applied to teeth to prevent cavities. This falls under the definition of a therapeutic device as it treats or prevents a condition (dental cavities).
No
The device is described as a pit and fissure sealant intended to prevent cavities, not to diagnose a condition.
No
The device description explicitly states it is composed of resin, which is a physical material, 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 "Pit and fissure sealant," which is a dental procedure performed directly on the patient's teeth.
- Device Description: The description clearly states it's a "pit and fissure sealant and conditioner" and describes its use in sealing teeth to prevent cavities. This is a therapeutic/preventative device used in vivo (on a living organism).
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
TEETHMATE F-1 is indicated for the following application: 1) Pit and fissure sealant
Product codes
EBC
Device Description
This product is classified into the pit and fissure sealant and conditioner, CFR 21 Section 872.3765, because it is a device composed of resin, such as polymethyl methacrylate, intended for use primary in young children to seal pit and fissure depressions in the biting surfaces of teeth to present cavities.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.
0
KO12742
Image /page/0/Picture/1 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" with a smaller letter "G" nested inside. Below the symbol, the word "KURARAY" is printed in a simple sans-serif font. The overall design is clean and geometric.
Dental Material Department 12-39, 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN : +81-6-348-2603 Phone Facsimile: +81-6-348-2552
KURARAY MEDICAL INC
510(k) SUMMARY
-
- Submitter
-
- Name
-
- Address
-
- Contact person
- Date 5) Contact person in U.S.A.
SEP 1 4 2001
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
- Name of Device
| 1) Proprietary Name | TEETHMATE F-1 |
|---|---|
| 2) Classification Name | Pit and fissure sealant and conditioner |
| 3) Common/Usual Name | Pit and fissure sealant |
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- 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.
- Predicate device:
The predicate device is as follow.
- TEETHMATE F-1 by Kuraray Co., Ltd. (K965091) 1.
-
- Description for the premarket notification
This product is classified into the pit and fissure sealant and conditioner, CFR 21 Section 872.3765, because it is a device composed of resin, such as polymethyl methacrylate, intended for use primary in young children to seal pit and fissure depressions in the biting surfaces of teeth to present cavities.
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- Statement of the intended use
The intended use of this device is as follow. It is completely the same as TEETHMATE F-1 manufactured by Kuraray Co., Ltd. (K965091)
- Statement of the intended use
- Pit and fissure sealant
-
- Statement of the technological characteristics and safety
This device is essentially the same as TEETHMATE F-1 manufactured by Kuraray Co., Ltd. (K965091). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as TEETHMATE F-1.
- Statement of the technological characteristics and safety
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines forming a profile. The figure is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 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: K012742
Trade/Device Name: Teethmate F-1 Regulation Number: 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC 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
2
Page 2 - Ms. Sasaki
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rice of 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 and insting (21 01 11 0 10 1 0 1 1 5 1 1 1 1 1 1 1 1 1 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 premiureet lease are 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,
[signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: TEETHMATE F-1
KO12742
Indications for Use
TEETHMATE F-1 is indicated for the following application: Pit and fissure sealant 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)
Susan Ruane
l Hospital Devices
Study number K012742