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FDA 510(k)

ET IV SA Dental Implants

K-Number: K183242 · 2019-05-21

ApplicantHiossen, Inc.
Decision Date2019-05-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ET IV SA Dental Implants is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2019-05-21 under approval number K183242. 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 ET IV SA Dental Implants?

ET IV SA Dental Implants is a medical device that received FDA 510(k) clearance on 2019-05-21. It is manufactured by Hiossen, Inc.. The 510(k) number is K183242.

When was ET IV SA Dental Implants approved by the FDA?

ET IV SA Dental Implants received FDA 510(k) clearance on 2019-05-21, under approval number K183242.

What company makes ET IV SA Dental Implants?

ET IV SA Dental Implants is manufactured by Hiossen, Inc..

What is the FDA product code for ET IV SA Dental Implants?

The FDA product code for ET IV SA Dental Implants is DZE.

Related Clinical Trials

NCT07608523 Marginal Bone Level Around Dental Implants in Periodontitis Patients COMPLETED NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT07240493 BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED

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

View all 16 devices →

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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