FDA 510(k)

K5

K-Number: K233805 · 2024-09-03

ApplicantOsstem Implant Co., Ltd. Chair Business

Decision Date2024-09-03

Product CodeEIA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

K5 is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd. Chair Business. It received FDA 510(k) clearance on 2024-09-03 under 510(k) number K233805. 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 K5?

K5 is a medical device that received FDA 510(k) clearance on 2024-09-03. The listed applicant is Osstem Implant Co., Ltd. Chair Business. The 510(k) number is K233805.

When did K5 receive FDA 510(k) clearance?

K5 received FDA 510(k) clearance on 2024-09-03, under 510(k) number K233805.

Who is the listed applicant for K5?

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

What is the FDA product code for K5?

The FDA product code for K5 is EIA.

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 Corporation K251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair Business K243130Integral 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.