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510(k) K060080

DIAGNODENT 2190 WITH PERIODONTAL PROBE by Kavo Dental Corporation — Product Code NTK

K060080 is an FDA 510(k) premarket notification submitted by Kavo Dental Corporation for the device "DIAGNODENT 2190 WITH PERIODONTAL PROBE". The FDA issued a decision of Substantially Equivalent on February 8, 2006. The device falls under product code NTK (Light Transmission Caries Detector), a Class II device regulated under 21 CFR 872.1745.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2006
Date Received
January 10, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Transmission Caries Detector
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

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FDA data resources