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FDA 510(k)

Luna Dental Implant System- Healing Abutment

K-Number: K200189 · 2020-02-26

ApplicantShinhung Mst Co., Ltd.
Decision Date2020-02-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Luna Dental Implant System- Healing Abutment is a medical device manufactured by Shinhung Mst Co., Ltd.. It received FDA 510(k) clearance on 2020-02-26 under approval number K200189. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Luna Dental Implant System- Healing Abutment?

Luna Dental Implant System- Healing Abutment is a medical device that received FDA 510(k) clearance on 2020-02-26. It is manufactured by Shinhung Mst Co., Ltd.. The 510(k) number is K200189.

When was Luna Dental Implant System- Healing Abutment approved by the FDA?

Luna Dental Implant System- Healing Abutment received FDA 510(k) clearance on 2020-02-26, under approval number K200189.

What company makes Luna Dental Implant System- Healing Abutment?

Luna Dental Implant System- Healing Abutment is manufactured by Shinhung Mst Co., Ltd..

What is the FDA product code for Luna Dental Implant System- Healing Abutment?

The FDA product code for Luna Dental Implant System- Healing Abutment is NHA.

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Related PubMed Literature

PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Shinhung Mst Co., Ltd.

K160106LUNA DENTAL IMPLANT SYSTEM K162867MagDen Dental Implant System K221752Stella K223395Luna Dental Implant System K221317S-Mono

Related Devices (Code: NHA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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