SEE-IT CARIES DETECTOR

K060330 · Ronvig Dental Mfg. A/S · LFC · Apr 7, 2006 · Dental

Device Facts

• Record ID: K060330
• Device Name: SEE-IT CARIES DETECTOR
• Applicant: Ronvig Dental Mfg. A/S
• Product Code: LFC · Dental
• Decision Date: Apr 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1740
• Device Class: Class 2

Intended Use

A visual aid for the identification of infected carious dentine.

Device Story

SEE-IT™ Caries Detector functions as a visual aid for dental professionals to identify infected carious dentine. Device assists clinicians during dental examinations by highlighting carious tissue, facilitating clinical decision-making regarding excavation and treatment. Used in dental clinic settings by dentists or dental hygienists. Device provides visual feedback to the operator, aiding in the differentiation between healthy and infected dentine to improve caries removal accuracy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Caries detection device (Product Code: LFC). Class II. Intended for professional dental use as a visual aid.

Indications for Use

Indicated for use as a visual aid for the identification of infected carious dentine in patients requiring dental caries assessment.

Regulatory Classification

Identification

The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its head and wings. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 7 2006

Ms. Annette Ravn Nielsen Export Manger RONVIG Dental Mfg. A/S Gl. Vejlevej 59 DK-8721 Daugaard DENMARK

Re: K060330

Trade/Device Name: SEE-IT™ Caries Detector Regulation Number: 872.1740 Regulation Name: Caries Detection Device Regulatory Class: II Product Code: LFC Dated: February 7, 2006 Received: February 9, 2006

Dear Ms. Nielsen:

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 Eedera! Register.

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Page 2 - Ms. Nielsen

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 [phone]. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

yznette Y. Michine Cons

Chiu Lin, Ph.D.

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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510(k) Number (if known):

K060330

Device Name:

:

SEE-IT™ Caries Detector

## INDICATIONS FOR USE

A visual aid for the identification of infected carious dentine.

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

Susan Dunne

v, General H

K060330

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use __ __ __ __

.

(Optional Format 1-2-96)

Exhibit 7