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510(k) K253236

G-BLOCK by Graphenano Dental S.L. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2025
Date Received
September 29, 2025
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
Yes

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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