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510(k) K210421

Diafil & Diafil Capsule by DiaDent Group International — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2021
Date Received
February 11, 2021
Clearance Type
Special
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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