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FDA 510(k)

TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment

K-Number: K220562 · 2022-11-10

ApplicantMegagen Implant Co., Ltd.
Decision Date2022-11-10
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2022-11-10 under approval number K220562. 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 TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment?

TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment is a medical device that received FDA 510(k) clearance on 2022-11-10. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K220562.

When was TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment approved by the FDA?

TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment received FDA 510(k) clearance on 2022-11-10, under approval number K220562.

What company makes TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment?

TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment is manufactured by Megagen Implant Co., Ltd..

What is the FDA product code for TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment?

The FDA product code for TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment is NHA.

Related Clinical Trials

NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT06636136 Transtibial Osseointegration RECRUITING

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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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