TEETHMATE F-1

• K Number: K012742
• Device Name: TEETHMATE F-1
• Manufacturer: KURARAY MEDICAL INC.
• Date Cleared: 2001-09-14 ( 31 days)
• Product Code: EBC
• Regulation Number: 872.3765
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: K965091
• Predicate For: N/A

Intended Use

TEETHMATE F-1 is indicated for the following application: 1) Pit and fissure sealant

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.

AI/ML Overview

There is insufficient information within the provided text to describe acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) summary for a dental material (TEETHMATE F-1), which primarily addresses its substantial equivalence to a predicate device for marketing purposes. It does not contain details about performance acceptance criteria or specific studies to demonstrate compliance.

The document discusses:

• Device Identification: TEETHMATE F-1, a pit and fissure sealant.
• Submission Purpose: To change the name and address of the manufacturer (Kuraray Co., Ltd. transferring business to Kuraray Medical Inc.).
• Predicate Device: TEETHMATE F-1 by Kuraray Co., Ltd. (K965091).
• Intended Use: Pit and fissure sealant.
• Technological Characteristics and Safety: Stated as "completely the same" as the predicate device.
• FDA Correspondence: Notification of substantial equivalence determination.

None of these sections detail performance metrics, acceptance criteria, or specific study designs (like sample sizes, expert qualifications, adjudication methods, or MRMC studies) related to the device's performance. The FDA's letter merely confirms the substantial equivalence determination based on the provided information, not necessarily on new performance studies.

Summary

{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 : [phone] Phone Facsimile: [phone]

KURARAY MEDICAL INC

510(k) SUMMARY

• 1. Submitter
  • 1. Name
  • 2. Address
  • 3. Contact person

4. 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 : [phone] Facsimile : (212)-867-3543

2. 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

• 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.

• TEETHMATE F-1 by Kuraray Co., Ltd. (K965091) 1.
• 4. 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.

• 5. 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)

1. Pit and fissure sealant

• 6. 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.

{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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

Regulation Number and Section

§ 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.