SUNLITELED MODEL #2810 by KINETIC INSTRUMENTS, INC.

The provided document is a 510(k) clearance letter from the FDA for a dental device called "SunliteLED Model #2810." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, a 510(k) clearance letter does not contain information about acceptance criteria, study designs, sample sizes, ground truth establishment, or expert qualifications in the detailed format requested. This type of information is typically found in the 510(k) submission itself, or in supporting technical documentation and study reports, which are not part of this public clearance letter.

The letter explicitly states: "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." It focuses on regulatory compliance and substantial equivalence to a predicate device, rather than providing a detailed performance study report.

Therefore, I cannot provide the requested information based solely on the text provided. The document confirms the device name, applicant, regulation number, and indications for use, but not the specific technical performance details of a study with acceptance criteria.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2001

Mr. William J. Becker President Kinetic Instruments, Incorporation 17 Berkshire Boulevard Bethel, Connecticut 06801

Re: K012946

Trade/Device Name: SuniteLed Model #2810 Regulation Number: 872.6070 Regulation Name: Dental Regulatory Class: II Product Code: EBZ Dated: September 1, 2001 Received: September 4, 2001

Dear Mr. Becker:

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.

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.

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Page 2 - Mr. Becker

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Timoth A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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KOI 2946

INDICATIONS FOR USE STATEMENT

Ver/ 3 - 4/24/96

Applicant: Kinetic Instruments Inc.

510(k) Number (if known): N/A

Device Name: SunliteLED

Indications For Use:

Light Activation System for Dental Restorative Resins

Susan Runno

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, and General Hospita 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.