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FDA 510(k)

K3

K-Number: K183347 · 2019-09-04

ApplicantOsstem Implant Co., Ltd.
Decision Date2019-09-04
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

K3 is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2019-09-04 under approval number K183347. 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 K3?

K3 is a medical device that received FDA 510(k) clearance on 2019-09-04. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K183347.

When was K3 approved by the FDA?

K3 received FDA 510(k) clearance on 2019-09-04, under approval number K183347.

What company makes K3?

K3 is manufactured by Osstem Implant Co., Ltd..

What is the FDA product code for K3?

The FDA product code for K3 is EIA.

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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