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FDA 510(k)

MRI Compatibility for Existing Straumann Dental Implant Systems

K-Number: K190662 · 2019-06-17

ApplicantStraumann USA, LLC
Decision Date2019-06-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MRI Compatibility for Existing Straumann Dental Implant Systems is a medical device manufactured by Straumann USA, LLC. It received FDA 510(k) clearance on 2019-06-17 under approval number K190662. 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 MRI Compatibility for Existing Straumann Dental Implant Systems?

MRI Compatibility for Existing Straumann Dental Implant Systems is a medical device that received FDA 510(k) clearance on 2019-06-17. It is manufactured by Straumann USA, LLC. The 510(k) number is K190662.

When was MRI Compatibility for Existing Straumann Dental Implant Systems approved by the FDA?

MRI Compatibility for Existing Straumann Dental Implant Systems received FDA 510(k) clearance on 2019-06-17, under approval number K190662.

What company makes MRI Compatibility for Existing Straumann Dental Implant Systems?

MRI Compatibility for Existing Straumann Dental Implant Systems is manufactured by Straumann USA, LLC.

What is the FDA product code for MRI Compatibility for Existing Straumann Dental Implant Systems?

The FDA product code for MRI Compatibility for Existing Straumann Dental Implant Systems is DZE.

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Related PubMed Literature

PMID: 40781789 Resorbable Bio-Inductive Collagen Implant for Rotator Cuff Repair: What We Know, What We Need to Know, and the Path Forward. Orthopaedic surgery (2025) PMID: 40774046 Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks. International dental journal (2025)

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 K171784Straumann Dental Implant System 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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