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510(k) K192284

DiaFil Flow by DiaDent Group International — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2020
Date Received
August 22, 2019
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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  • K192392 — DiaPlus (May 26, 2020)
  • K190091 — Diapaste (March 27, 2020)

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