Bone Chamber Implant
K-Number: K223339 · 2023-07-18
ApplicantMegagen Implant Co., Ltd.
Decision Date2023-07-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Bone Chamber Implant is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2023-07-18 under approval number K223339. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bone Chamber Implant?
Bone Chamber Implant is a medical device that received FDA 510(k) clearance on 2023-07-18. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K223339.
When was Bone Chamber Implant approved by the FDA?
Bone Chamber Implant received FDA 510(k) clearance on 2023-07-18, under approval number K223339.
What company makes Bone Chamber Implant?
Bone Chamber Implant is manufactured by Megagen Implant Co., Ltd..
What is the FDA product code for Bone Chamber Implant?
The FDA product code for Bone Chamber Implant is DZE.
Related Clinical Trials
Other Devices by Megagen Implant Co., Ltd.
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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.