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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 a medical device manufactured by P&A USA. It received FDA 510(k) clearance on 2025-07-09 under approval 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. It is manufactured by P&A USA. The 510(k) number is K243731.

When was HEXIM Implant; Samwon General Abutments approved by the FDA?

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

What company makes HEXIM Implant; Samwon General Abutments?

HEXIM Implant; Samwon General Abutments is manufactured by P&A USA.

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 Clinical Trials

NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT06796504 The SetPoint System as a Pro-Remyelination Therapy for Relapsing-Remitting Multiple Sclerosis: A Pilot Study RECRUITING NCT06945731 The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Weight Loss in Overweight and Obese Patients COMPLETED NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT03714412 Feasibility Study of Patients With Severe MR Treated With the Cardiovalve TMVR System WITHDRAWN

Related Devices (Code: DZE)

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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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