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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 the device name listed in this FDA 510(k) record. The listed applicant is Shinhung Mst Co., Ltd.. It received FDA 510(k) clearance on 2020-02-26 under 510(k) 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. The listed applicant is Shinhung Mst Co., Ltd.. The 510(k) number is K200189.

When did Luna Dental Implant System- Healing Abutment receive FDA 510(k) clearance?

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

Who is the listed applicant for Luna Dental Implant System- Healing Abutment?

The FDA 510(k) record lists Shinhung Mst Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07246499Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues.COMPLETEDNCT07636265The Effect Of Photobiomodulation On Dental Implant SurvivalCOMPLETEDNCT07687615Cover Screw vs Healing Abutment on OsseointegrationCOMPLETEDNCT07727980Tissue Preservation in Immediate 1C Implants Using an Anatomical Prefabricated Healing AbutmentNOT_YET_RECRUITINGNCT04695899Zirconia Implants for Replacement of a Single ToothACTIVE_NOT_RECRUITINGNCT05122897Investigation of Biofilm Formation on Temporary push-on Rings of Implant CrownsRECRUITING

Other records listing Shinhung Mst Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221752StellaK223395Luna Dental Implant SystemK221317S-MonoK162867MagDen Dental Implant SystemK160106LUNA DENTAL IMPLANT SYSTEM

Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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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