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510(k) K150601

Zeramic Adhesive Resin Cement by Premier Dental Company Products — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2015
Date Received
March 10, 2015
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

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