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510(k) K261071

DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) by DiaDent Group International — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2026
Date Received
April 1, 2026
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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Other clearances for product code EBF

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