510(k) K142130

ORAL BOND by Steiner Laboratories — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2016
Date Received
August 4, 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