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FDA 510(k)

HEXIM Implant; Samwon General Abutments

K-Number: K243731 · 2025-07-09

ApplicantP&A USA
Decision Date2025-07-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HEXIM Implant; Samwon General Abutments is the device name listed in this FDA 510(k) record. The listed applicant is P&A USA. It received FDA 510(k) clearance on 2025-07-09 under 510(k) number K243731. 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 HEXIM Implant; Samwon General Abutments?

HEXIM Implant; Samwon General Abutments is a medical device that received FDA 510(k) clearance on 2025-07-09. The listed applicant is P&A USA. The 510(k) number is K243731.

When did HEXIM Implant; Samwon General Abutments receive FDA 510(k) clearance?

HEXIM Implant; Samwon General Abutments received FDA 510(k) clearance on 2025-07-09, under 510(k) number K243731.

Who is the listed applicant for HEXIM Implant; Samwon General Abutments?

The FDA 510(k) record lists P&A USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEXIM Implant; Samwon General Abutments?

The FDA product code for HEXIM Implant; Samwon General Abutments is DZE.

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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