510(k) K200555

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) by Prevest Denpro Limited — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2021
Date Received
March 3, 2020
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