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FDA 510(k)

UNIQA Dental Implants System

K-Number: K180598 · 2018-08-08

ApplicantUniqa Dental, Ltd.
Decision Date2018-08-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNIQA Dental Implants System is a medical device manufactured by Uniqa Dental, Ltd.. It received FDA 510(k) clearance on 2018-08-08 under approval number K180598. 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 UNIQA Dental Implants System?

UNIQA Dental Implants System is a medical device that received FDA 510(k) clearance on 2018-08-08. It is manufactured by Uniqa Dental, Ltd.. The 510(k) number is K180598.

When was UNIQA Dental Implants System approved by the FDA?

UNIQA Dental Implants System received FDA 510(k) clearance on 2018-08-08, under approval number K180598.

What company makes UNIQA Dental Implants System?

UNIQA Dental Implants System is manufactured by Uniqa Dental, Ltd..

What is the FDA product code for UNIQA Dental Implants System?

The FDA product code for UNIQA Dental Implants System 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 NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018)

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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