510(k) K081903

XIOS PLUS WALL-MODULE by Sirona Dental Systems GmbH — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2008
Date Received
July 3, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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