FLASH-LITE II LED DENTAL CURING LIGHT by DISCUS DENTAL, INC.

This document is a 510(k) clearance letter from the FDA for a dental curing light, not a study report or a document detailing acceptance criteria and performance data for a device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, and does not contain:

A table of acceptance criteria and reported device performance.
Sample size used for a test set or data provenance.
Number or qualifications of experts for ground truth.
Adjudication methods.
Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Results of a standalone algorithm performance study.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for a training set.
How ground truth for a training set was established.

This document is a formal communication from the FDA granting market clearance, not a technical report or clinical study summary.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing the human services aspect of the department. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

Mr. Garv L. Hollar Director, Regulatory Affairs Discus Dental, Incorporated 8550 Higuera Street Culver City, California 90232

Re: K023748

Trade/Device Name: FLASH-lite IITM Dental Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: November 07, 2002 Received: November 08, 2002

Dear Mr. Hollar:

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 vour 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. Gary L. Hollar

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 (OS) 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,

Timothy A. Ulatowski 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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Ko23748 510(k) Number (if known):

Device Name: FLASH-lite II Dental Curing Light

Indications for Use:

Source of illumination for curing photo-activated, visible light cured dental restorative materials.

Susan Runner

v. General Hospital.

510(k) Number: K052348

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

Prescription Use √
(Per 21 CFR801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

510(K) Notification Discus Dental, Inc.

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.