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510(k) Data Aggregation
K Number
K063321Device Name
D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138
Manufacturer
NEKS TECHNOLOGIES, INC.
Date Cleared
2007-03-30
(148 days)
Product Code
NBL
Regulation Number
872.1745Why did this record match?
Applicant Name (Manufacturer) :
NEKS TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aid in diagnosis of dental pits and fissures and interproximal caries and aid in the detection of dental calculus.
Device Description
The D-Carie probe contains optical fibers that read the optical scattering characteristic of dental carie thru healthy enamel structure above (the marginal ridge over the vulnerable inteproximal area) and convert it into an electrical signal. From that signal a computer analysis identifies the dental caries. The device can be in either in a new handheld or a tabletop (original) format with the addition or not of the calculus detection feature of the Detectar.
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K Number
K043156Device Name
D-CARIE, MODEL N121-M1
Manufacturer
NEKS TECHNOLOGIES, INC.
Date Cleared
2005-04-28
(164 days)
Product Code
NBL
Regulation Number
872.1745Why did this record match?
Applicant Name (Manufacturer) :
NEKS TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
D-Carie is indicated for aiding in the diagnosis of dental carries
Device Description
Similar to the Diagnodent the D-CARIE is indicated for use in aiding in the diagnosis of dental caries. The D-CARIE probe is similar in intended use, size, and shape to a Diagnodent probe tip. Identical to the technology in the Detectar the D-CARIE probe contains an optical fiber that reads the optical signature of suspicious areas and converts it into an electrical signal. From that electrical signal a computer analysis identifies areas that need further examination.
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