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510(k) Data Aggregation
K Number
K093705Device Name
FUORECAM
Manufacturer
Date Cleared
2010-04-23
(143 days)
Product Code
Regulation Number
872.1745Why did this record match?
Applicant Name (Manufacturer) :
THERAPEUTIC TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FluoreCam™ is intended to be used as an aid in the diagnosis of dental caries.
The FluoreCam™ is indicated as an aid in the diagnosis of dental caries.
Device Description
The FluoreCam™ consists of a handheld instrument that interfaces with custom computer software via a USB connection. The instrument excites the surface of a tooth with light and transmits images of the surface to the software. The software quantifies carious activity using the auto fluorescent property of tooth enamel.
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