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FDA 510(k)

N1 TiUltra TCC Implant System

K-Number: K211109 · 2021-12-21

ApplicantNobel Biocare Services AG
Decision Date2021-12-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

N1 TiUltra TCC Implant System is a medical device manufactured by Nobel Biocare Services AG. It received FDA 510(k) clearance on 2021-12-21 under approval number K211109. 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 N1 TiUltra TCC Implant System?

N1 TiUltra TCC Implant System is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Nobel Biocare Services AG. The 510(k) number is K211109.

When was N1 TiUltra TCC Implant System approved by the FDA?

N1 TiUltra TCC Implant System received FDA 510(k) clearance on 2021-12-21, under approval number K211109.

What company makes N1 TiUltra TCC Implant System?

N1 TiUltra TCC Implant System is manufactured by Nobel Biocare Services AG.

What is the FDA product code for N1 TiUltra TCC Implant System?

The FDA product code for N1 TiUltra TCC Implant System is DZE.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) 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) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Nobel Biocare Services AG

K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray K220339Esthetic Abutments Nobel Biocare N1 K220048NobelProcera Zirconia N1 Base K231219NobelZygoma PureSet™ Tray

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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