SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L

K061658 · Dentall Corp. · EBZ · Sep 18, 2006 · Dental

Device Facts

• Record ID: K061658
• Device Name: SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L
• Applicant: Dentall Corp.
• Product Code: EBZ · Dental
• Decision Date: Sep 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2

Intended Use

Non-diagnostic intraoral camera used by dentists to illuminate and magnify dental surfaces.

Device Story

Spirit/DocPortMacro is a non-diagnostic intraoral camera; functions as an imaging tool for dentists. Device captures visual data of oral cavity; provides illumination and magnification of dental surfaces. Used in dental clinic settings by dental professionals. Output displayed for visual inspection of teeth and gums; assists in patient communication and documentation of oral conditions. Does not provide diagnostic information.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Intraoral camera system; includes illumination source and optical magnification components. Operates as a non-diagnostic imaging accessory for dental operative units. Class I device.

Indications for Use

Indicated for use by dentists as a non-diagnostic intraoral camera to provide illumination and magnification of dental surfaces.

Regulatory Classification

Identification

An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

Submission Summary (Full Text)

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 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 faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 8 2006

Dentall Corporation C/O Mr. Edwin First DME Dezigns 3 Faraday #B Irvine, California 92618

Re: K061658

Trade/Device Name: Spirit/DocPortMacro Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: May 24, 2006 Received: June 29, 2006

Dear Mr. First:

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. First

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.

Senate Y. Michien Omd.

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

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

Premarket notification Dentall Corp.

510(k) Number (If known)_

Device Name __________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Non-diagnostic intraoral camera used by dentists to illuminate and magnify dental surfaces.

(Please do not write below this line-continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (Per 21 CFR 801.109) Over-the-counter use

Susan Runne

or

L. sion of Anesthesiology, General Hospital, Moction Control, Dental Devices

Number: 5061658