VERACAM

K021083 · Lumalite, Inc. · EIA · Aug 30, 2002 · Dental

Device Facts

• Record ID: K021083
• Device Name: VERACAM
• Applicant: Lumalite, Inc.
• Product Code: EIA · Dental
• Decision Date: Aug 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The intra-oral camera system, Veracam, of Lumalite, Inc. is used to provide a view of the mouth so that it assists the dentist in describing dental procedures to a patient and to show a patient a before view and an after view of procedures which the dentist has performed on him.

Device Story

Veracam is an intra-oral camera system used by dentists in a clinical setting. The device captures visual images of the oral cavity, allowing the dentist to display these images to the patient. The primary function is to assist in patient communication by providing a visual aid for describing dental procedures and demonstrating before-and-after results of performed treatments. The system consists of the camera unit and associated accessories.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intra-oral camera system; Class I device (Product Code EIA); Regulation 872.6640 (Dental Operative Unit and Accessories).

Indications for Use

Indicated for dental patients requiring visual examination of the oral cavity to assist dentists in patient education and procedure demonstration.

Regulatory Classification

Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle's head with three profiles facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle's head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2002

Lumalite, Incorporated C/O Mr. W. Edward Johansen W. Edward Johansen 11661 San Vicente Boulevard Los Angeles, California 90049

Re: K021083

Trade/Device Name: Veracam; Intra-Oral Camera System and Accessories Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: July 5, 2002 Received: July 8, 2002

Dear Mr. Johansen:

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. Johansen

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski 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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## PRE-MARKET NOTIFICATION

INDICATIONS FOR USE

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: Veracam, intra-oral camera system and accessories

Indications for Use:

The intra-oral camera system, Veracam, of Lumalite, Inc. is used to provide a view of the mouth so that it I IIC intraction canced systems, Forecallites and to show a patient a before view and an after view of assists the dellife in describitits dollar procedures which the dentist has performed on him.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ____________________________________________________________________________________________________________________________________________________________

Over The Counter Use: _ : (Per 21 CFR 801.109)

Robert Sbetz DDS for Dr Susan Lunner

Division Sian-Off Division of Anesthesiology, General Hospital. Infection Control. Dental I 510(k) Number: