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FDA 510(k)

Straumann Dental Implant System

K-Number: K171784 · 2018-01-19

ApplicantStraumann USA, LLC
Decision Date2018-01-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann Dental Implant System is a medical device manufactured by Straumann USA, LLC. It received FDA 510(k) clearance on 2018-01-19 under approval number K171784. 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 Straumann Dental Implant System?

Straumann Dental Implant System is a medical device that received FDA 510(k) clearance on 2018-01-19. It is manufactured by Straumann USA, LLC. The 510(k) number is K171784.

When was Straumann Dental Implant System approved by the FDA?

Straumann Dental Implant System received FDA 510(k) clearance on 2018-01-19, under approval number K171784.

What company makes Straumann Dental Implant System?

Straumann Dental Implant System is manufactured by Straumann USA, LLC.

What is the FDA product code for Straumann Dental Implant System?

The FDA product code for Straumann Dental 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 Straumann USA, LLC

K151590Straumann RN Gold Abutment for Bridge K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment K190662MRI Compatibility for Existing Straumann Dental Implant Systems K192401Straumann Screw-Retained Abutments K203753Straumann Surgical Cassettes K202942Straumann 4 mm Short Implants

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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