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FDA 510(k)

N1

K-Number: K232012 · 2023-11-28

ApplicantOsstem Implant Co., Ltd.
Decision Date2023-11-28
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

N1 is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2023-11-28 under approval number K232012. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N1?

N1 is a medical device that received FDA 510(k) clearance on 2023-11-28. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K232012.

When was N1 approved by the FDA?

N1 received FDA 510(k) clearance on 2023-11-28, under approval number K232012.

What company makes N1?

N1 is manufactured by Osstem Implant Co., Ltd..

What is the FDA product code for N1?

The FDA product code for N1 is EHD.

Other Devices by Osstem Implant Co., Ltd.

K161197Orthodontic Screw K153015Transfer & Angled Abutment K160519Link Abutment for CEREC K161604OSSTEM Implant System K170736HySil Impression Materials K161689OSSTEM Implant System - 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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