510(k) K073461

ORTHO ANCHOR SCREWS by Mis Implants Technologies , Ltd. — Product Code OAT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 25, 2008
Date Received: December 10, 2007
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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