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510(k) K254112

Dia-X Sil Bite by DiaDent Group International — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2026
Date Received
December 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type

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