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FDA 510(k)

GEN5™ and GEN5+™ 3.3mmD Dental Implants

K-Number: K252145 · 2025-12-23

ApplicantParagon Implant Mfg., LLC
Decision Date2025-12-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GEN5™ and GEN5+™ 3.3mmD Dental Implants is the device name listed in this FDA 510(k) record. The listed applicant is Paragon Implant Mfg., LLC. It received FDA 510(k) clearance on 2025-12-23 under 510(k) 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. The listed applicant is Paragon Implant Mfg., LLC. The 510(k) number is K252145.

When did GEN5™ and GEN5+™ 3.3mmD Dental Implants receive FDA 510(k) clearance?

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

Who is the listed applicant for GEN5™ and GEN5+™ 3.3mmD Dental Implants?

The FDA 510(k) record lists Paragon Implant Mfg., LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Paragon Implant Mfg., LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250476NizPlant Dental Implant SystemK251756Sterilization TraysK251938GEN5 and GEN5+ Dental Implant System

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , 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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