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510(k) K242317

Integrated Endo System (Meet Endo-II) by Denjoy Dental Co., Ltd. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2025
Date Received
August 5, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

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