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510(k) K133088

ZX-27 by M&M Dental Studio, Inc. — Product Code EJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2015
Date Received
September 30, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anchor, Preformed
Device Class
Class I
Regulation Number
872.3130
Review Panel
DE
Submission Type