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510(k) K190871

Bio-TackS Orthodontic Mini Implant by Biocetec Co., Ltd. — Product Code OAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2020
Date Received
April 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Orthodontic
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

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