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FDA 510(k)

MRI Compatibility for Existing Straumann Dental Implant Systems

K-Number: K190662 · 2019-06-17

Decision Date2019-06-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MRI Compatibility for Existing Straumann Dental Implant Systems is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC. It received FDA 510(k) clearance on 2019-06-17 under 510(k) 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. The listed applicant is Straumann USA, LLC. The 510(k) number is K190662.

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

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

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

The FDA 510(k) record lists Straumann USA, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

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.

Other records listing Straumann USA, LLC as applicant

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.

View all 9 devices →

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.

Official Source

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