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510(k) K254245

ZAFIRA® by New Stetic, SA — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2026
Date Received
December 29, 2025
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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  • K102874 — NEW STETIC ACRYLICS (March 28, 2011)

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