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510(k) K250969

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST by Dent4you AG — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2025
Date Received
March 31, 2025
Clearance Type
Abbreviated
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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