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510(k) K250009

LED Curing Light (C01-X, C02-X) by Premium Plus (Dongguan) Limited — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2025
Date Received
January 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activator, Ultraviolet, For Polymerization
Device Class
Class II
Regulation Number
872.6070
Review Panel
DE
Submission Type

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