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510(k) K200189

Luna Dental Implant System- Healing Abutment by Shinhung Mst Co., Ltd. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2020
Date Received
January 27, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Other clearances by Shinhung Mst Co., Ltd.

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  • K223395 — Luna Dental Implant System (February 3, 2023)
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  • K162867 — MagDen Dental Implant System (July 26, 2017)
  • K160106 — LUNA DENTAL IMPLANT SYSTEM (August 26, 2016)
  • K123155 — LUNA DENTAL IMPLANT SYSTEM (October 31, 2013)

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