510(k) K100960

WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS by Cefla Dental Group — Product Code MUH

K100960 is an FDA 510(k) premarket notification submitted by Cefla Dental Group for the device "WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS". The FDA issued a decision of Substantially Equivalent on October 21, 2010. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Cefla Dental Group has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2010
Date Received
April 7, 2010
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