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510(k) K150218

Fill-Up! by Coltene/Whaledent AG — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2015
Date Received
January 30, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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