510(k) K111465

COMPOTHIXO by Kerrhawe SA — Product Code DZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2012
Date Received
May 26, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Dental Hand
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type