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510(k) K251239

GrandioSO Unlimited by Voco GmbH — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2025
Date Received
April 22, 2025
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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