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510(k) K221194

LEDEX by Dentmate Technology Co. , Ltd. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2022
Date Received
April 25, 2022
Clearance Type
Abbreviated
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

Other clearances by Dentmate Technology Co. , Ltd.

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