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FDA 510(k)

EK D3.3 and Ultra Wide Implants

K-Number: K240232 · 2024-09-13

ApplicantHiossen, Inc.
Decision Date2024-09-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EK D3.3 and Ultra Wide Implants is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2024-09-13 under approval number K240232. 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 EK D3.3 and Ultra Wide Implants?

EK D3.3 and Ultra Wide Implants is a medical device that received FDA 510(k) clearance on 2024-09-13. It is manufactured by Hiossen, Inc.. The 510(k) number is K240232.

When was EK D3.3 and Ultra Wide Implants approved by the FDA?

EK D3.3 and Ultra Wide Implants received FDA 510(k) clearance on 2024-09-13, under approval number K240232.

What company makes EK D3.3 and Ultra Wide Implants?

EK D3.3 and Ultra Wide Implants is manufactured by Hiossen, Inc..

What is the FDA product code for EK D3.3 and Ultra Wide Implants?

The FDA product code for EK D3.3 and Ultra Wide Implants is DZE.

Related Clinical Trials

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Other Devices by Hiossen, Inc.

K153332ETIII SA Fixture System (O3.2mm) K151542A-Oss K151626ET III Bio-SA Fixture System K162390ET Hybrid Abutment K180527IS3 K170421ET Hybrid Abutment

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Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., 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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