Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Dental, Inc.. It received FDA 510(k) clearance on 2017-05-17 under 510(k) 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. The listed applicant is Zimmer Dental, Inc.. The 510(k) number is K160398.

When did MRI Compatibility for Existing Zimmer Dental Implant Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for MRI Compatibility for Existing Zimmer Dental Implant Systems?

The FDA 510(k) record lists Zimmer Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03917927A Clinical Study of the Eztetic Dental Implant SystemCOMPLETEDNCT05439330Application of a Dental-dedicated MRI in the Diagnosis of Temporomandibular Joint Disorders, Tissue Alterations Related to Third Molars, Periapical and Periodontal Inflammatory Diseases, and Implant Treatment PlanningRECRUITINGNCT06948162Exploration of the Utility of Dental-dedicated MRI for DentistryRECRUITING

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , 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.

↑