CARIES INDICATOR

K030807 · Confi-Dental Products Co. · LFC · Jun 9, 2003 · Dental

Device Facts

• Record ID: K030807
• Device Name: CARIES INDICATOR
• Applicant: Confi-Dental Products Co.
• Product Code: LFC · Dental
• Decision Date: Jun 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1740
• Device Class: Class 2

Intended Use

Caries Indicator is indicated for the following applications: Designed to be used to help identify caries in dentin.

Device Story

Caries Indicator is a dental diagnostic aid used by clinicians to identify carious lesions within dentin. The device is applied to the tooth structure to assist the practitioner in visualizing or distinguishing decayed dentin from healthy tissue during restorative procedures. It functions as a visual aid to guide the removal of caries, potentially improving the precision of cavity preparation and preserving healthy tooth structure. It is intended for professional use in a dental clinic setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's classification and intended use.

Technological Characteristics

Chemical-based caries detection agent. Formulated for application to dentin to provide visual contrast for carious tissue identification. Class II device under 21 CFR 872.1740.

Indications for Use

Indicated for use in identifying caries in dentin.

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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2003

Mr. Stephen Rudolph Quality Manager Confi-Dental Products Company 416 South Taylor Avenue Louisville, Colorado 80027

Re: K030807

Trade/Device Name: Caries Indicator Regulation Number: 872.1740 Regulation Name: Caries Detection Device Regulatory Class: II Product Code: LFC Dated: March 10, 2003 Received: March 13, 2003

Dear Mr. Rudolph:

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 - Mr. Rudolph

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/dsma/dsmamain.html

Sincerely yours,

Susan Runser

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

Enclosure

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Ver/ 3 - 4/24/96

Applicant: Confi-Dental Products Company

510% number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Device Name: Caries Indicator

Indications for Use:

Caries Indicator is indicated for the following applications:

Designed to be used to help identify caries in dentin.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Ke Muly Samsa

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

510(k) Number: K030807

(Optional Format 1-2-96)