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): August 20, 1998
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 N. Westlake Blvd., Suite 202
Westlake Village, CA 91362
(Address of Principal Executive Offices)
(805) 381-2700
(Registrant's Telephone Number)
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ITEM 5. OTHER EVENTS
Reference is made to the press release of Registrant, issued on August
20, 1998, which contains information meeting the requirements of this Item 5,
and which is incorporated herein by this reference. A copy of the press release
is attached to this Form 8-K as Exhibit 99.1.
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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.
August 20, 1998 Dental/Medical Diagnostic Systems, Inc.
By: /s/Stephen Ross
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Stephen Ross
Chief Financial Officer
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EXHIBIT INDEX
EXHIBITS
99.1 Press Release dated August 20, 1998
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EXHIBIT 99.1
Contact:
Dental/Medical Diagnostic Systems, Inc.
200 N. Westlake Blvd., Suite 202
Westlake Village, CA 91362
Robert H. Gurevitch, CEO/Chairman Stephen D. Axelrod, CFA
Stephen F. Ross, CFO Nancy S. L. Block
(805) 381-2700; (805) 374-1966 (Fax) Susan T. Bolen (Media)
e-mail:[email protected] Wolfe Axelrod Associates
(212)370-4500; (212)370-4505(FAX)
For Immediate Release: e-mail:[email protected]
August 20, 1998
DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. ANNOUNCES
IT HAS RECEIVED 510(K) NOTIFICATION FOR THE APOLLO 95E TOOTH
WHITENING AND COMPOSITE CURING SYSTEM
WESTLAKE VILLAGE, CA., August 20, 1998, Dental/Medical Diagnostic Systems,
Inc. (NASDAQ: DMDS, DMDSW) today announced that is has received 510(k)
notification for the Apollo 95E tooth whitening and curing system from the
United States Food and Drug Administration (FDA) pursuant to Section 510(k) of
the federal Food, Drug and Cosmetic Act.
This notification allows Dental/Medical Diagnostic Systems, Inc. to begin
marketing the Apollo 95E and shipping will commence immediately.
The Apollo 95E tooth whitening and composite curing system, developed by
Dental/Medical Diagnostic Systems, Inc., will significantly whiten discolored
teeth in less that one hour. Because the Apollo 95E is not a laser, a dental
assistant can perform the procedure. The Apollo 95E non-laser curing light, also
cures restorative composite materials in 1 to 3 seconds, making it the fastest
dental curing light in the world known to the Company. Dental/Medical Diagnostic
Systems, Inc. will be supplying its own matched composites and whitening
materials to increase speed and optimize results for the dentist and the
patient.
Robert H. Gurevitch, Chairman and CEO of Dental/Medical Diagnostic Systems,
Inc., stated, "The swift approval of our 510(k) filing for the Apollo 95E tooth
whitening and curing system supports the earlier confidence of our regulatory
experts that notification wouldnt take more than 60 to 90 days. We expect the
Apollo 95E to quickly garner a significant share of the market for tooth
whitening devices and composite curing because of its market leading combination
of price and features."
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Dental/Medical Diagnostic Systems, Inc. designs, develops, manufactures and
sells high technology dental equipment. Currently, the Company sells an
intraoral camera system known as the TeliCam System, a dental office networking
system known as InTELInet and a tooth whitening and curing system, the Apollo
95E, that began shipping outside the United States in the first quarter. In a
separate agreement, the Company is supporting the development of a
state of-the-art dental Digital X-ray system, which is expected to be marketed
in early 1999.
Disclosure Regarding Forward Looking Statements.
This press release includes forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933 (Securities Act) and Section 21E of
the Securities Exchange Act of the 1934 (the Exchange Act). Although the Company
believes that the expectations reflected in such forward-looking statements are
reasonable at this time, it can give no assurance that such expectations will
prove to have been correct. Forward- looking statements involve numerous risks
and uncertainties. The success of the Apollo 95E including (i) the ability of
the company to forecast market trends and preferences and adapt the Apollo 95E
to market requirements, (ii) the ability of the Company to develop and implement
a manufacturing capability for the Apollo 95E in the United States, and (iii)
the rapid technological change that is a characteristic of the dental device
market may render existing products, or products under development, obsolete or
unmarketable. As a result of these factors and other important risks and
uncertainties described in the Companys most recently filed Form 10KSB report
which should be read in conjunction herewith, copies of which are available from
the Companys Investor Relations department, actual results may differ materially
from those contemplated by the forward-looking statements set forth herein. The
Company expressly disclaims any obligation or undertaking to release publicly
any updates or revisions to any statement herein or to reflect any change in the
Companys expectations or any change in events, conditions or circumstances on
which any such statement is based.
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