(66 days)
Not Found
Not Found
No
The summary describes a dental adhesive system and does not mention any AI or ML components or functionalities.
No
The device is a dental adhesive system used for bonding composite material to teeth or fractured porcelain/composite, which is a structural or restorative function, not generally considered therapeutic in the sense of treating a disease or condition.
No
Explanation: The device is described as a dental adhesive system used for bonding composite material to enamel, dentin, or fractured porcelain/composite for repair. Its function is to physically bond materials, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly indicates it is a dental adhesive system, 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 describes the device as a dental adhesive system for bonding composite materials to teeth and fractured dental materials. This is a direct application within the mouth for restorative dental procedures.
- Device Description: The description reinforces its function as a dental adhesive.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
The device is clearly intended for use in vivo (within the body) during dental treatment.
N/A
Intended Use / Indications for Use
The TOKUYAMA BOND FORCE resin tooth bonding agent device is intended for the bonding of light- or dual-cured composite material to (i) cut or uncut enamel, (ii) cut or uncut dentin, or (iii) fractured porcelain or composite for repair.
Product codes
KLE
Device Description
TOKUYAMA BOND FORCE is a one-component, one-coat application, self-etching, light-cured, fluoride-releasing dental adhesive system. The adhesive can be cured using a light curing unit with a camphorquinone (CQ) wavelength range (400 - 500 mm range). The device is intended for the bonding of light- or dual-cured composite material to (i) cut or uncut enamel, (ii) cut or uncut dentin, or (iii) fractured porcelain or composite for repair.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel, dentin, fractured porcelain or composite
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
(670215
510(k) SUMMARY Tokuyama Dental Corporation TOKUYAMA BOND FORCE
MAR 3 0 2007
Name of Device
Trade or Proprietary Name: Common Name: Classification Name: Product Code:
TOKUYAMA BOND FORCE resin tooth bonding agent agent, tooth bonding, resin KLE
Preparation Date
January 10, 2007
510(k) Sponsor
Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan
510(k) Sponsor Contact
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
Intended Use
TOKUYAMA BOND FORCE is a one-component, one-coat application, self-etching, light-cured, fluoride-releasing dental adhesive system. The adhesive can be cured using a light curing unit with a camphorquinone (CQ) wavelength range (400 - 500 mm range). The device is intended for the bonding of light- or dual-cured composite material to (i) cut or uncut enamel, (ii) cut or uncut dentin, or (iii) fractured porcelain or composite for repair.
l
1
Technological Characteristics and Substantial Equivalence
The TOKUYAMA BOND FORCE device is substantially equivalent to multiple predicate devices with respect to biocompatibility, bond strength, and fluoride release rate. Although the TOKUYAMA BOND FOR.CE may have slightly different performance characteristics than the predicate devices, these differences do not raise new questions of safety or effectiveness.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tokuyama Dental Corporation C/O Mr. Robert A. Silverman Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005
MAR 3 0 2007
Re: K070215
Trade/Device Name: TOKUYAMA BOND FORCE Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: January 22, 2007 Received: January 24, 2007
Dear Mr. Silverman:
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.
3
Page 2 – Mr. Silverman
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 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 legally 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), please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Sylvia Y. Michieu Dms.
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
4
Indications for Use
KU7C215 510(k) Number (if known): unknown
Device Name: TOKUYAMA BOND FORCE
Indications for Use:
The TOKUYAMA BOND FORCE resin tooth bonding agent device is intended for the bonding of light- or dual-cured composite material to (i) cut or uncut enamel, (ii) cut or uncut dentin, or (iii) fractured porcelain or composite for repair.
Prescription Use V (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Subey Rumer
nesiology, Ganeral Hr
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C(k) Number,