510(k) K172918

DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) by Kavo Dental Technologies, LLC — Product Code MUH

K172918 is an FDA 510(k) premarket notification submitted by Kavo Dental Technologies, LLC for the device "DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)". The FDA issued a decision of Substantially Equivalent on December 18, 2017. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2017
Date Received
September 25, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type