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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2024-12-27 under 510(k) 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. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K241972.

When did BLUEDIAMOND IMPLANT receive FDA 510(k) clearance?

BLUEDIAMOND IMPLANT received FDA 510(k) clearance on 2024-12-27, under 510(k) number K241972.

Who is the listed applicant for BLUEDIAMOND IMPLANT?

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

What is the FDA product code for BLUEDIAMOND IMPLANT?

The FDA product code for BLUEDIAMOND IMPLANT is DZE.

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

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.

K251232MegaGen Zygoma Dental Implant SystemK242030MegaGen Dental Implant AbutmentK234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentK240754N2K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown ScrewK231967ARi ExCon Implant System

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Related Devices (Code: DZE)

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.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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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