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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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Form 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): December 18, 1997
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware 0-12850 13-3152648
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
200 North Westlake Boulevard, Suite 202
Westlake Village, California 91362
(Address of Principal Executive Offices)
(805) 381-2700
(Registrant's Telephone Number)
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ITEM 5. OTHER EVENTS
The Company has been notified by the staff of the United States Food and
Drug Administration ("FDA") of its view that the Company is required to file
and obtain clearance of a pre-market notification (a "510(k) Notification")
pursuant to Section 510(k) of the Federal Food, Drug and Cosmetic Act ("FDC
Act") in connection with the sale by the Company of its TeliCam intraoral
dental camera. The staff of the FDA has orally indicated to the Company that
the Company will not be required to suspend sales of the TeliCam System pending
clearance of its 510(k) Notification. Although the Company believes that the
marketing and sale of the TeliCam intraoral dental camera does not require
filing or clearance of a 510(k) Notification and would vigorously challenge
any enforcement action based upon such a contention, the Company has determined
to promptly comply with the FDA staff's direction.
The Company had previously determined not to submit a 510(k) Notification
based on advice from its regulatory experts that although the FDA had not
specifically classified intraoral dental cameras, certain other similar
devices, including a surgical camera and a fiber-optic dental light, had been
classified by the FDA as Class I devices exempt from 510(k) Notification and
that the Company's intraoral dental camera was therefore likely to be treated
in the same manner provided that it was marketed only for use in assisting
patient communications and in providing a record in order to facilitate
insurance payment or reimbursement. The Company did not promote the TeliCam
intraoral dental camera for diagnostic uses.
In general, clearance of a 510(k) Notification may be obtained if a
manufacturer or seller of medical devices can establish that a new device is
"substantially equivalent" to a predicate device other than one that has an
approved premarket approval application ("PMA"). PMAs are substantially more
rigorous approvals generally applicable only to life sustaining, life
supporting or implantable devices, as well as certain novel technology or new
intended uses or applications for existing devices. The claim for substantial
equivalence in a 510(k) Notification may have to be supported by various types
of information, including clinical data, indicating that the device is as safe
and effective for its intended use as its legally marketed equivalent device.
Generally, the 510(k) Notification is required to be cleared by the FDA prior
to introducing a device into commercial distribution. OBTAINING market
clearance for a 510(k) Notification submission may take 2 TO 8 months or
longer. The process of obtaining required regulatory clearances or approvals
can be time-consuming and expensive, and there can be no assurance that the
required regulatory clearances will be obtained, or that the FDA will not
change its position and seek to suspend sales of the TeliCam intraoral dental
camera WHILE A 510(K) NOTIFICATION IS PENDING.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
December 18, 1997
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC.
By: /S/ Ronald E. Wittman
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Ronald E. Wittman
Chief Financial Officer
