510(k) K050019

IN EXAM INTRAORAL DENTAL X-RAY SYSTEM by Kavo America — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2005
Date Received
January 5, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type