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510(k) Data Aggregation
K Number
K973410Device Name
ULTRACAM
Manufacturer
Date Cleared
1998-10-08
(394 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
W. EDWARD JOHANSEN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intraoral camera system, Ultracam, of Dental Vision Direct, 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 Description
Ultracam, intraoral camera system and accessories
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