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FDA 510(k)

BLUEDIAMOND IMPLANT, Abutment Screw

K-Number: K211812 · 2023-01-06

ApplicantMegagen Implant Co., Ltd.
Decision Date2023-01-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BLUEDIAMOND IMPLANT, Abutment Screw 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 2023-01-06 under 510(k) number K211812. 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, Abutment Screw?

BLUEDIAMOND IMPLANT, Abutment Screw is a medical device that received FDA 510(k) clearance on 2023-01-06. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K211812.

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

BLUEDIAMOND IMPLANT, Abutment Screw received FDA 510(k) clearance on 2023-01-06, under 510(k) number K211812.

Who is the listed applicant for BLUEDIAMOND IMPLANT, Abutment Screw?

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, Abutment Screw?

The FDA product code for BLUEDIAMOND IMPLANT, Abutment Screw is DZE.

Related Clinical Trials

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.

NCT06636136Transtibial OsseointegrationRECRUITINGNCT07687615Cover Screw vs Healing Abutment on OsseointegrationCOMPLETEDNCT07701200OT-Bridge System Versus Multiunit Abutment for Mandibular All On-4 Screw Retained Prostheses.COMPLETED

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 AbutmentK241972BLUEDIAMOND IMPLANTK234142TiGEN 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 Screw

View all 23 devices →

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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