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FDA 510(k)

NobelZygoma TiUltra Implant system

K-Number: K243834 · 2025-08-25

ApplicantNobel Biocare AB
Decision Date2025-08-25
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NobelZygoma TiUltra Implant system is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2025-08-25 under approval number K243834. 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 NobelZygoma TiUltra Implant system?

NobelZygoma TiUltra Implant system is a medical device that received FDA 510(k) clearance on 2025-08-25. It is manufactured by Nobel Biocare AB. The 510(k) number is K243834.

When was NobelZygoma TiUltra Implant system approved by the FDA?

NobelZygoma TiUltra Implant system received FDA 510(k) clearance on 2025-08-25, under approval number K243834.

What company makes NobelZygoma TiUltra Implant system?

NobelZygoma TiUltra Implant system is manufactured by Nobel Biocare AB.

What is the FDA product code for NobelZygoma TiUltra Implant system?

The FDA product code for NobelZygoma TiUltra Implant system is DZE.

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

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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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