AEGIS PIT & FISSURE SEALANT WITH ACP by HARRY J. BOSWORTH CO.

The provided text is a 510(k) premarket notification letter from the FDA regarding the "Aegis® Pit & Fissure Sealant." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML or diagnostic devices.

The letter is a regulatory document stating that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory compliance and general controls but does not include technical study details.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details based on the provided text. The requested information types (e.g., test set sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are characteristic of performance evaluations for diagnostic or AI/ML-driven devices, which are not described in this regulatory clearance letter for a dental sealant.

Summary

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2004

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

Re: K033751

Trade/Device Name: Aegis® Pit & Fissure Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Codes: EBC Dated: January 21, 2004 Received: January 27, 2004

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 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Chis S. Liu, Ph.D.

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

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14033751 510(K) Number:

Device Name: Aegis Pit & Fissure Sealant with ACP

INDICATIONS FOR USE:

Aegis Pit & Fissure Sealant with ACP is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth.

The Aegis Pit & Fissure Sealant with ACP is available in opaque and tinted shades, when different shades are indicated for use.

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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)

Susan Runne

(Division Sign-Off) (Division Sign-Onl)
Division of Anesthesiology General Hospital Division Control. Dental Devices

510(k) Number _

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.