ORACAM

K020957 · Video Dental Concepts, Inc. · EIA · Jun 13, 2002 · Dental

Device Facts

• Record ID: K020957
• Device Name: ORACAM
• Applicant: Video Dental Concepts, Inc.
• Product Code: EIA · Dental
• Decision Date: Jun 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Indications for Use

The OraCam is used to provide Intra oral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy allowing the dentist to examine patient's teeth in order for them to adequately plan in the treatment.

Device Story

OraCam is an intra-oral camera system used by dentists to capture high-resolution images of the oral cavity and teeth. The device functions as an imaging tool to assist clinicians in visual examination and treatment planning. It provides magnified, accurate pictorial representations of dental structures. The system is intended for use in a dental clinic setting. By providing clear visual data, it aids the dentist in identifying dental conditions and communicating treatment needs to the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intra-oral camera system; digital imaging sensor; handheld form factor; intended for dental diagnostic visualization.

Indications for Use

Indicated for dental patients requiring intra-oral imaging for examination and treatment planning.

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.

Reference Devices

• Stomavision
• Vipercam
• Telicam
• Digital Doc
• S555
• S575
• MiniCam
• Smilie PC systems

Submission Summary (Full Text)

{0}------------------------------------------------

## 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 features a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2002

Mr. Claude D. Berthoin President Video Dental Concepts 110 East Granada Boulevard, Suite 208 P.O. Box 36 Ormond Beach, Florida 32175-0036

Re: K020957

Trade/Device Name: OraCam Regulation Number: 872.6640 Regulation Name: Intra-Oral Camera Regulatory Class: I Product Code: EIA Dated: March 20, 2002 Received: March 25, 2002

Dear Mr. Claude:

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.

{1}------------------------------------------------

Page 2 - Mr. Berthoin

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 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,

Patricia Cucurullo for

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

{2}------------------------------------------------

Page 2_of 2

## 价020957

510(k) Number (if known): Applied for Device Name: __OraCam

Indications for Use:

The OraCam is used to provide Intra oral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy allowing the dentist to examine patient's teeth in order for them to adequately plan in the treatment.

The OraCam is therefore similar in indicated use as Stomavision, Vipercam, Telicam, Digital Doc, S555 and S575, MiniCam and Smilie PC systems, in its intended use.

Susan Rinn

(Division Sign-Off) Division of Dental, Infection Control, Division of Dental, Infrection Continues
and General Hospital Devicess
E Lifki Number 510(k) Number ________________________________________________________________________________________________________________________________________________________________