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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 the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2019-09-04 under 510(k) 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. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K183347.

When did K3 receive FDA 510(k) clearance?

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

Who is the listed applicant for K3?

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

What is the FDA product code for K3?

The FDA product code for K3 is EIA.

Other records listing Osstem Implant Co., Ltd. as applicant

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Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, 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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