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FDA 510(k)

Dental Implants OKTAGON Tissue Level and Bone Level

K-Number: K162073 · 2017-02-24

Decision Date2017-02-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Implants OKTAGON Tissue Level and Bone Level is the device name listed in this FDA 510(k) record. The listed applicant is Hager& Meisinger GmbH. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K162073. 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 Dental Implants OKTAGON Tissue Level and Bone Level?

Dental Implants OKTAGON Tissue Level and Bone Level is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Hager& Meisinger GmbH. The 510(k) number is K162073.

When did Dental Implants OKTAGON Tissue Level and Bone Level receive FDA 510(k) clearance?

Dental Implants OKTAGON Tissue Level and Bone Level received FDA 510(k) clearance on 2017-02-24, under 510(k) number K162073.

Who is the listed applicant for Dental Implants OKTAGON Tissue Level and Bone Level?

The FDA 510(k) record lists Hager& Meisinger GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Implants OKTAGON Tissue Level and Bone Level?

The FDA product code for Dental Implants OKTAGON Tissue Level and Bone Level 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 Hager& Meisinger GmbH 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.

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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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