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FDA 510(k)

HexaPLUS S OneDrill Implant System

K-Number: K243078 · 2025-10-10

ApplicantOsseofuse International, Inc.
Decision Date2025-10-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HexaPLUS S OneDrill Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Osseofuse International, Inc.. It received FDA 510(k) clearance on 2025-10-10 under 510(k) number K243078. 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 HexaPLUS S OneDrill Implant System?

HexaPLUS S OneDrill Implant System is a medical device that received FDA 510(k) clearance on 2025-10-10. The listed applicant is Osseofuse International, Inc.. The 510(k) number is K243078.

When did HexaPLUS S OneDrill Implant System receive FDA 510(k) clearance?

HexaPLUS S OneDrill Implant System received FDA 510(k) clearance on 2025-10-10, under 510(k) number K243078.

Who is the listed applicant for HexaPLUS S OneDrill Implant System?

The FDA 510(k) record lists Osseofuse International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HexaPLUS S OneDrill Implant System?

The FDA product code for HexaPLUS S OneDrill Implant System is DZE.

Other records listing Osseofuse International, Inc. 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.

K181157Conical Plus Implant System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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