DIGITAL DOC

K981663 · Digital Doc, LLC · EIA · Aug 10, 1998 · Dental

Device Facts

• Record ID: K981663
• Device Name: DIGITAL DOC
• Applicant: Digital Doc, LLC
• Product Code: EIA · Dental
• Decision Date: Aug 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

Intended Use

The intraoral camera system, Digital Doc, of Digital Doc, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.

Device Story

Intraoral camera system; captures visual images of oral cavity; assists dentists in patient communication; displays before-and-after views of dental procedures; used in dental clinic setting; operated by dental professionals; output viewed by dentist and patient to facilitate understanding of treatment outcomes.

Technological Characteristics

Intraoral camera system; class I device; product code EIA.

Indications for Use

Indicated for use by dentists to provide intraoral visualization to assist in patient education, procedure description, and demonstration of before-and-after treatment 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three overlapping profiles, suggesting a sense of community and interconnectedness. The profiles are rendered in black and are arranged in a way that creates a sense of depth and movement. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 1998

Mr. W. Edward Johansen Digital Doc, Incorporated 11661 San Vicente Boulevard Los Angeles, California 90049

Re : K981663 Diqital Doc Trade Name: Requlatory Class: I Product Code: EIA July 22, 1998 Dated: Received: July 22, 1998

Dear Mr. Johansen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰਾ substantially equivalent determination assumes compliance with -the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Paqe 2 - Mr. Johansen

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 807.97). *Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Dutman for

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

Enclosure ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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## PREMARKET NOTIFICATION

INDICATIONS FOR USE

510 (k) Number Device Name: Digital Doc, intraoral camera system and

## accessories

Indications for Use:

The intraoral camera system, Digital Doc, of Digital Doc, Inc. is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rimpis

OR

Division Sign-Off) ivision of Dental, Infection Control, and General Hospital Device 510(k) Number

Prescription Use:

Over-The-Counter-Use: _

(Per 21 CFR 801.109