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510(k) K172821

Ti-one 101 TS Dental Implant System by Hung Chun Bio-S Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2018
Date Received
September 18, 2017
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

Other clearances by Hung Chun Bio-S Co., Ltd.

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