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510(k) K183347

K3 by Osstem Implant Co., Ltd. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 2019
Date Received
December 3, 2018
Clearance Type
Traditional
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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