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510(k) K231395

INNO SLA Submerged Narrow Implant System by Cowellmedi Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2023
Date Received
May 15, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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  • K090049 — ATLAS IMPLANT SYSTEM- MINI PLUS (April 20, 2009)

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