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FDA 510(k)

Straumann PURE Ceramic Implant System

K-Number: K180477 · 2019-01-04

ApplicantInstitut Straumann AG
Decision Date2019-01-04
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann PURE Ceramic Implant System is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2019-01-04 under approval number K180477. 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 PURE Ceramic Implant System?

Straumann PURE Ceramic Implant System is a medical device that received FDA 510(k) clearance on 2019-01-04. It is manufactured by Institut Straumann AG. The 510(k) number is K180477.

When was Straumann PURE Ceramic Implant System approved by the FDA?

Straumann PURE Ceramic Implant System received FDA 510(k) clearance on 2019-01-04, under approval number K180477.

What company makes Straumann PURE Ceramic Implant System?

Straumann PURE Ceramic Implant System is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann PURE Ceramic Implant System?

The FDA product code for Straumann PURE Ceramic 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 Institut Straumann AG

K161677Straumann Sterile Healing Solution K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, K153758Straumann Bone Level Tapered Implants K171773Straumann n!ce Glass Ceramic A14 Blocks K173410n!ce for Planmill K162848Straumann CARES Golden Ti/TiN Abutments

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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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