FDA 510(k)

GEN5 and GEN5+ 3.3mmD Dental Implants

K-Number: K252145 · 2025-12-23

Decision Date2025-12-23

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GEN5 and GEN5+ 3.3mmD Dental Implants is a medical device manufactured by Paragon Implant Mfg., LLC. It received FDA 510(k) clearance on 2025-12-23 under approval number K252145. 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 GEN5 and GEN5+ 3.3mmD Dental Implants?

GEN5 and GEN5+ 3.3mmD Dental Implants is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Paragon Implant Mfg., LLC. The 510(k) number is K252145.

When was GEN5 and GEN5+ 3.3mmD Dental Implants approved by the FDA?

GEN5 and GEN5+ 3.3mmD Dental Implants received FDA 510(k) clearance on 2025-12-23, under approval number K252145.

What company makes GEN5 and GEN5+ 3.3mmD Dental Implants?

GEN5 and GEN5+ 3.3mmD Dental Implants is manufactured by Paragon Implant Mfg., LLC.

What is the FDA product code for GEN5 and GEN5+ 3.3mmD Dental Implants?

The FDA product code for GEN5 and GEN5+ 3.3mmD 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 Paragon Implant Mfg., LLC

K250476NizPlant Dental Implant System K251756Sterilization Trays K251938GEN5 and GEN5+ Dental Implant System

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.