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510(k) K123155

LUNA DENTAL IMPLANT SYSTEM by Shinhung Mst Co., Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2013
Date Received
October 9, 2012
Clearance Type
Abbreviated
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 Shinhung Mst Co., Ltd.

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  • K162867 — MagDen Dental Implant System (July 26, 2017)
  • K160106 — LUNA DENTAL IMPLANT SYSTEM (August 26, 2016)

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