CONTEC LIGHT by DENTAURUM | FDA 510(k) Summary

This request cannot be fulfilled. The document provided is an FDA 510(k) clearance letter for a dental light curing device called "ConTec Light". It confirms substantial equivalence to a predicate device and allows the manufacturer to market it.

However, the document does NOT contain any information regarding:

Acceptance criteria table or reported device performance metrics (e.g., accuracy, sensitivity, specificity).
Any details about a study that proves the device meets specific performance criteria.
Sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive performance studies with detailed statistical analyses as might be found in a PMA (Premarket Approval) submission for a novel, high-risk device, or a publication describing a clinical trial for an AI-powered diagnostic.

Therefore, I cannot extract the requested information from the provided text.

Summary

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Public Health Service

JUN 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jan W. A. Doorschodt General Manager Dentaurum, Incorporated 10 Pheasant Run Newton, Pennsylvania 18940

Re: K030641

Trade/Device Name: ConTec Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ Dated: May 27, 2003 Received: May 30, 2003

Dear Mr.Doorschodt:

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. Jan W. A. Doorschodt

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 vour 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.

Susan Rimmer

Susan Runner, DDS, MA Interim 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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510 (k) NUMBER (K030641):

Enclosure 1

DEVICE NAME: ConTec Light

INDICATIONS FOR USE:

ConTec Light is used to set resinous dental adhesive material by transmission of visible light.

(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' ________________________________________________________________________________________________________________________________________________________

Kee Mulay So MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic

510(k) Number: K030641

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.