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FDA 510(k)

URIS Long Implant & Abutments

K-Number: K243255 · 2025-07-03

ApplicantTruabutment, Inc.
Decision Date2025-07-03
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

URIS Long Implant & Abutments is a medical device manufactured by Truabutment, Inc.. It received FDA 510(k) clearance on 2025-07-03 under approval number K243255. 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 URIS Long Implant & Abutments?

URIS Long Implant & Abutments is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Truabutment, Inc.. The 510(k) number is K243255.

When was URIS Long Implant & Abutments approved by the FDA?

URIS Long Implant & Abutments received FDA 510(k) clearance on 2025-07-03, under approval number K243255.

What company makes URIS Long Implant & Abutments?

URIS Long Implant & Abutments is manufactured by Truabutment, Inc..

What is the FDA product code for URIS Long Implant & Abutments?

The FDA product code for URIS Long Implant & Abutments is DZE.

Related Clinical Trials

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

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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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