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510(k) K242360

Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator by Dent4you AG — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2024
Date Received
August 9, 2024
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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