510(k) K073209

MAXCEM 2 by Kerr Corporation — Product Code MZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2008
Date Received
November 14, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type