BOSWORTH BOND by HARRY J. BOSWORTH CO.

Bosworth Bond is an all-in-one 2-component etch and prime material. Bosworth Bond is used for etching and giving a initial bond coat in one step prior to enamel bonding resin cements and orthodontic adhesives. It changes color on mixing. When the material has cured on the tooth, color disappears, leaving a clear bond.

Dye-free 1- or 2-component versions are available. They do not change color. If a dry tooth enamel bonding surface is present, the 2-component Bosworth Bond is employed. looki onamel surface is kept moist to slightly wet, then only the Part B component needs to be used.

Device Description

AI/ML Overview

I am sorry, but the provided text content does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a dental bonding agent called "Bosworth Bond" (K043170). It discusses the device's substantial equivalence to predicate devices and outlines regulatory requirements. It does not include:

A table of acceptance criteria and device performance.
Details about sample sizes, data provenance, or the number/qualifications of experts.
Adjudication methods, MRMC studies, or standalone algorithm performance.
Information on ground truth types, training set sizes, or how training set ground truth was established.

Therefore, I cannot fulfill your request based on the provided text.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2005

Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076

Re: K043170

Trade/Device Name: Bosworth Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 17, 2005 Received: February 18, 2005

Dear Ms. Goldstein:

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 -- Ms. Mildred M. Goldstein

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that TDA S Issualice of a substition with other requirements of the Act or that FDA nas made a determination mar your as a read to vother Federal agencies. You must comply with any Federal statures and regulations administered by 10: registration and listing (21 CFR Part 807); all the Act s requirements, including, but not interest requirements as set forth in the quality.
Iabeling (21 CFR Part 801); good manufacturing practice requirements as set labeling (21 CFR Part 801), good manazation of applicable, the electronic product radiation Systems (QD) regarders 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) I his letter will anow you to begin marketing your antial equivalence of your device to a legally premarket nothication. "The IDA midning of backannal requence 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 If you desire specific advice 101 your as (240) 276-0115. Also, please note the regulation entitled, Comact the Office of Comphanes at (210) of CFR Part 807.97). You may obtain other Misoranting of reference to promaibilities under the Act from the Division of Small general information on your responsibilities at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Clats

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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Page 1 of 1

510(K) Number: _K043170

Device Name: Bosworth Bond

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-the-Counter Use (Optional Format 1/2/96)

Siva Kumar

Sian-Off Crision of Anesthesiology, General Hospital, Chection Control, Dental Devices

Number: K043170

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.