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510(k) K160097

Image Fast Set, Image Regular Set by Sybron Dental Specialties — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2016
Date Received
January 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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