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Found 2 results

510(k) Data Aggregation

K Number

Device Name

REMOTE VIEW SOFTWARE

Manufacturer

CARIESCAN LTD.

Date Cleared

2011-05-17

(6 days)

Product Code

NBL

Regulation Number

872.1745

Why did this record match?

Applicant Name (Manufacturer) :

CARIESCAN LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

Device Description

Not Found

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K Number

Device Name

CARIESCAN PRO

Manufacturer

CARIESCAN LTD.

Date Cleared

2009-12-15

(285 days)

Product Code

NBL

Regulation Number

872.1745

Why did this record match?

Applicant Name (Manufacturer) :

CARIESCAN LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

For use by dental professionals as an aid in the diagnosis and monitoring of dental caries.

Device Description

This submission is for a handheld dental caries detection device which uses the AC impedance spectroscopy technique (ACIST). Single use disposal sensors are connected to the handheld device. The sensor is placed on the tooth site to be measured and a metal lip hook is placed on the patients lip, a small electrical current is passed between the sensor and the lip hook, the signals returned indicate any mineral changes in the tooth structure.

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