ELCACAM

K032070 · A-Dec, Inc. · EIA · Aug 27, 2003 · Dental

Device Facts

• Record ID: K032070
• Device Name: ELCACAM
• Applicant: A-Dec, Inc.
• Product Code: EIA · Dental
• Decision Date: Aug 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The intraoral camera system, ElcaCam, is used to provide intraoral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy. It will assist the dentist in examining patient's teeth to facilitate treatment planning and describing their dental procedures. It will also be used to show a "before" view and an after "view" of the patient's mouth for visual confirmation of dental procedure results. The ElcaCam is not intended for use as an operative device and is not manufactured to be sterilized.

Device Story

ElcaCam is an intraoral camera system used by dentists to capture high-resolution images of the oral cavity. The device functions as a diagnostic aid for examination, treatment planning, and patient communication; it provides visual documentation of dental conditions before and after procedures. The system is not an operative device and is not intended for sterilization. It assists clinicians in visualizing dental structures to facilitate patient consultation and clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intraoral camera system; non-sterile; non-operative. Technical specifications and materials not detailed in the provided documentation.

Indications for Use

Indicated for use by dentists to capture intraoral images of teeth and mouth for examination, treatment planning, patient education, and visual confirmation of dental procedure results.

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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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2003

Mr. Tom Louisell Regulatory Affairs Scientist A-dec. Incorporated 2601 Crestview Drive Newberg, Oregon 97132

Re: K032070

Trade/Device Name: ElcaCam Intraoral Camera Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: June 26, 2003 Received: July 03, 2003

Dear Mr. Louisell:

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. Tom Louisell

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]. 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) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Suren Runne

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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K032070 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: ElcaCam

Indications For Use:

The intraoral camera system, ElcaCam, is used to provide intraoral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy. It will assist the dentist in examining patient's teeth to facilitate treatment planning and describing their dental procedures. It will also be used to show a "before" view and an after "view" of the patient's mouth for visual confirmation of dental procedure results.

The ElcaCam is not intended for use as an operative device and is not manufactured to be sterilized.

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.............................................................................................................................................................................. .............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OROver-The-Counter Use (Optional Format 1-2-96)

Kein Muly for KSN

(Division Sign-Off)

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K032070