(45 days)
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No
The summary describes a dental bonding agent, a chemical material, and makes no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as a dental bonding agent used for filling restorations of teeth and pretreatment for crown restorations, which are therapeutic medical purposes aimed at treating or alleviating conditions in the tooth.
No
This device is a dental bonding agent used for restoration and repair purposes, not for diagnosing conditions. Its function is to bond composite resin to various materials like tooth, metal, and porcelain.
No
The device description clearly states it consists of three materials (ETCHANT, PRIMER, and BONDING AGENT), which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental bonding agent used to bond materials to the tooth and for crown restorations. This is a direct application within the body (or on a part of the body) for a therapeutic or restorative purpose.
- Device Description: The description reinforces its use as a dental bonding agent for direct application in dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVDs are used to perform tests on samples taken from the body, not applied to the body itself for treatment or restoration.
N/A
Intended Use / Indications for Use
FL-BOND II is a dental bonding agent for composite resin to bond light-cured dental composite resin to tooth, metal, porcelain and resin for crown restorations. It consists of 3 materials, ETCHANT, PRIMER, and BONDING AGENT. Specific uses are as follows:
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- Filling restoration of tooth
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- Pretreatment of tooth, to which crown restoration is bonded using dental adhesive resin cement
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- Repair of crown restoration
Product codes
KLE, EMA
Device Description
FL-BOND II is a dental bonding agent for composite resin to bond light-cured dental composite resin to tooth, metal, porcelain and resin for crown restorations. It consists of 3 materials, ETCHANT, PRIMER, and BONDING AGENT.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Tooth
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is presented in black and white.
JUL - 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David P. Morais Operations Manager and Official Correspondent Shofu Dental Corporation 1225 Stone Drive San Marcos, California 92078-4059
Re: K071452 Trade/Device Name: FL BOND II Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EMA Dated: May 23, 2007 Received: May 25, 2007
Dear Mr. Morais:
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.
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Page 2 - Mr. David P. Morais
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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suptie y. Michael Smits.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: FL Bond II
Indications For Use:
FL-BOND II is a dental bonding agent for composite resin to bond light-cured dental composite resin to tooth, metal, porcelain and resin for crown restorations. It consists of 3 materials, ETCHANT, PRIMER, and BONDING AGENT. Specific uses are as follows:
-
- Filling restoration of tooth
-
- Pretreatment of tooth, to which crown restoration is bonded using dental adhesive resin cement
-
- Repair of crown restoration
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ken Hiley for MSR
Shofu Dental Corporation Civision of Anesthesiology. General Ho FL Bond II 510(k) Premarket Notification Control, Dental
510(k) Number:
X