510(k) K080738

DENTRON SENSOR by Dentron Systems, LLC — Product Code EAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2008
Date Received
March 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type