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510(k) K160106

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2016
Date Received
January 19, 2016
Clearance Type
Special
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)
  • K123155 — LUNA DENTAL IMPLANT SYSTEM (October 31, 2013)

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