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FDA 510(k)

BTI Interna 3.0 Dental Implant System UnicCa®

K-Number: K240262 · 2024-10-10

ApplicantB.T.I. Biotechnology Institute, Sl.
Decision Date2024-10-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BTI Interna 3.0 Dental Implant System UnicCa® is a medical device manufactured by B.T.I. Biotechnology Institute, Sl.. It received FDA 510(k) clearance on 2024-10-10 under approval number K240262. 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 BTI Interna 3.0 Dental Implant System UnicCa®?

BTI Interna 3.0 Dental Implant System UnicCa® is a medical device that received FDA 510(k) clearance on 2024-10-10. It is manufactured by B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K240262.

When was BTI Interna 3.0 Dental Implant System UnicCa® approved by the FDA?

BTI Interna 3.0 Dental Implant System UnicCa® received FDA 510(k) clearance on 2024-10-10, under approval number K240262.

What company makes BTI Interna 3.0 Dental Implant System UnicCa®?

BTI Interna 3.0 Dental Implant System UnicCa® is manufactured by B.T.I. Biotechnology Institute, Sl..

What is the FDA product code for BTI Interna 3.0 Dental Implant System UnicCa®?

The FDA product code for BTI Interna 3.0 Dental Implant System UnicCa® 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 B.T.I. Biotechnology Institute, Sl.

K151391BTI Dental Implant System UnicCa K173257BTI Dental Implant System UnicCa K202825BTI Extra-Short Dental Implant System UnicCa K213106BTI Interna Dental Implant System UnicCa - Prosthetic Components K211952BTI Interna Narrow/Plus Dental Implant System UnicCa K232750BTI Interna Prosthetic Components

View all 8 devices →

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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