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FDA 510(k)

DESS® Dental Implants

K-Number: K251280 · 2025-07-23

ApplicantTerrats Medical SL
Decision Date2025-07-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DESS® Dental Implants is a medical device manufactured by Terrats Medical SL. It received FDA 510(k) clearance on 2025-07-23 under approval number K251280. 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 DESS® Dental Implants?

DESS® Dental Implants is a medical device that received FDA 510(k) clearance on 2025-07-23. It is manufactured by Terrats Medical SL. The 510(k) number is K251280.

When was DESS® Dental Implants approved by the FDA?

DESS® Dental Implants received FDA 510(k) clearance on 2025-07-23, under approval number K251280.

What company makes DESS® Dental Implants?

DESS® Dental Implants is manufactured by Terrats Medical SL.

What is the FDA product code for DESS® Dental Implants?

The FDA product code for DESS® 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 Terrats Medical SL

K170588DESS Dental Smart Solutions K173908DESS Dental Smart Solutions K191986DESS Dental Smart Solutions K212538DESS Dental Implants K212577DESS Dental Smart Solutions K203464DESS Dental Smart Solutions

View all 22 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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