510(k) K110747

TEMPFLEX by Kerr Corporation — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2011
Date Received
March 17, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type