K5
K-Number: K233805 · 2024-09-03
Decision Date2024-09-03
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
K5 is a medical device manufactured by Osstem Implant Co., Ltd. Chair Business. It received FDA 510(k) clearance on 2024-09-03 under approval 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. It is manufactured by Osstem Implant Co., Ltd. Chair Business. The 510(k) number is K233805.
When was K5 approved by the FDA?
K5 received FDA 510(k) clearance on 2024-09-03, under approval number K233805.
What company makes K5?
K5 is manufactured by Osstem Implant Co., Ltd. Chair Business.
What is the FDA product code for K5?
The FDA product code for K5 is EIA.
Related Devices (Code: EIA)
K161734Vanguard Dental UnitRitter Concept GmbH
K161488ESTETICA Dental Treatment Unit and AccessoriesKaltenbach & Voigt GmbH
K151996TAURUS C1Shinhung Company, Ltd.
K152100Evogue Dental UnitTakara Belmont Corporation
K152830K3Osstem Implant Co., Ltd.
K173608Forest Dental UnitForest Dental Products, Inc.
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.