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510(k) K111809

SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS by Biomaterials Korea, Inc. — Product Code OAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2011
Date Received
June 27, 2011
Clearance Type
Special
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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  • K063495 — C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS (July 26, 2007)

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  • K211992 — Ortho MI System (October 15, 2021)
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