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510(k) K251491

K5 Cart, K5 Mount, K5 Swing by Osstem Implant Company., Ltd. Chair Business — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2025
Date Received
May 14, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

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