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FDA 510(k)

N2

K-Number: K211556 · 2023-04-05

ApplicantMegagen Implant Co., Ltd.
Decision Date2023-04-05
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

N2 is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2023-04-05 under approval number K211556. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N2?

N2 is a medical device that received FDA 510(k) clearance on 2023-04-05. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K211556.

When was N2 approved by the FDA?

N2 received FDA 510(k) clearance on 2023-04-05, under approval number K211556.

What company makes N2?

N2 is manufactured by Megagen Implant Co., Ltd..

What is the FDA product code for N2?

The FDA product code for N2 is EIA.

Other Devices by Megagen Implant Co., Ltd.

K192347ST Internal Implant System K182448AnyRidge Octa 1 Implant System K191127Advanced Intermezzo Implant System K190096R2GATE K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment K203808Multi-unit Abutment, Multi-unit Angled Abutment

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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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