BLUEDIAMOND IMPLANT
K-Number: K241972 · 2024-12-27
ApplicantMegagen Implant Co., Ltd.
Decision Date2024-12-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BLUEDIAMOND IMPLANT is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2024-12-27 under approval number K241972. 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 BLUEDIAMOND IMPLANT?
BLUEDIAMOND IMPLANT is a medical device that received FDA 510(k) clearance on 2024-12-27. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K241972.
When was BLUEDIAMOND IMPLANT approved by the FDA?
BLUEDIAMOND IMPLANT received FDA 510(k) clearance on 2024-12-27, under approval number K241972.
What company makes BLUEDIAMOND IMPLANT?
BLUEDIAMOND IMPLANT is manufactured by Megagen Implant Co., Ltd..
What is the FDA product code for BLUEDIAMOND IMPLANT?
The FDA product code for BLUEDIAMOND IMPLANT is DZE.
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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.