FL BOND II by SHOFU DENTAL CORP.

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

Device Description

AI/ML Overview

This document is a 510(k) clearance letter for a dental bonding agent (FL Bond II) and primarily focuses on the regulatory approval based on substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or performance study report would.

Therefore, most of the requested information cannot be extracted from the provided text. The document is a regulatory approval, not a performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

A table of acceptance criteria and the reported device performance
- Not provided. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning its performance is considered comparable to existing, approved devices. However, explicit acceptance criteria and corresponding reported performance metrics are not detailed in this regulatory letter.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This information would typically be found in a study report, not a 510(k) clearance letter.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. This letter does not describe a study involving expert readers or ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not provided. This device is a dental bonding agent, which is a material, not an AI or imaging device that would typically involve MRMC studies for human reader performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not provided. This is not an algorithm, but a physical dental product.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided.
The sample size for the training set
- Not provided.
How the ground truth for the training set was established
- Not provided.

In summary: The provided FDA 510(k) clearance letter confirms that the FL Bond II dental bonding agent has been deemed substantially equivalent to a predicate device. It defines the "Indications For Use" (listed as filling restoration, pretreatment for crown bonding, and repair of crown restoration). However, it does not include the detailed performance study results, acceptance criteria, or ground truth establishment methods typically found in a clinical trial report or a performance evaluation study.

Summary

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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

K071452

510(k) Number (if known):

Device Name: FL Bond II

Indications For Use:

1. Filling restoration of tooth
1. Pretreatment of tooth, to which crown restoration is bonded using dental adhesive resin cement
1. 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:

Regulation Number and Section

§ 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.