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510(k) K172106

SHOFU MZ Primer Plus by Shofu Dental Corporation — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2017
Date Received
July 12, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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