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510(k) K161335

Dual Top Screw System by Jeil Medical Corporation — Product Code OAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2017
Date Received
May 12, 2016
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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