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FDA 510(k)

AnyOne External Implant System

K-Number: K203554 · 2021-08-28

ApplicantMegagen Implant Co., Ltd.
Decision Date2021-08-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AnyOne External Implant System 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 2021-08-28 under 510(k) number K203554. 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 AnyOne External Implant System?

AnyOne External Implant System is a medical device that received FDA 510(k) clearance on 2021-08-28. The listed applicant is Megagen Implant Co., Ltd.. The 510(k) number is K203554.

When did AnyOne External Implant System receive FDA 510(k) clearance?

AnyOne External Implant System received FDA 510(k) clearance on 2021-08-28, under 510(k) number K203554.

Who is the listed applicant for AnyOne External Implant System?

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 AnyOne External Implant System?

The FDA product code for AnyOne External Implant System 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 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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