510(k) K141503

DENALI 501CEMENT by Denali Corporation — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2014
Date Received
June 6, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type