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FDA 510(k)

MRI Compatibility for Existing Zimmer Dental Implant Systems

K-Number: K160398 · 2017-05-17

ApplicantZimmer Dental, Inc.
Decision Date2017-05-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MRI Compatibility for Existing Zimmer Dental Implant Systems is a medical device manufactured by Zimmer Dental, Inc.. It received FDA 510(k) clearance on 2017-05-17 under approval number K160398. 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 Zimmer Dental Implant Systems?

MRI Compatibility for Existing Zimmer Dental Implant Systems is a medical device that received FDA 510(k) clearance on 2017-05-17. It is manufactured by Zimmer Dental, Inc.. The 510(k) number is K160398.

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

MRI Compatibility for Existing Zimmer Dental Implant Systems received FDA 510(k) clearance on 2017-05-17, under approval number K160398.

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

MRI Compatibility for Existing Zimmer Dental Implant Systems is manufactured by Zimmer Dental, Inc..

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

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

Related Clinical Trials

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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)

Related Devices (Code: DZE)

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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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