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FDA 510(k)

Internal Hex Implant System

K-Number: K190837 · 2020-01-22

ApplicantEbi, Inc.
Decision Date2020-01-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Internal Hex Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, Inc.. It received FDA 510(k) clearance on 2020-01-22 under 510(k) number K190837. 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 Internal Hex Implant System?

Internal Hex Implant System is a medical device that received FDA 510(k) clearance on 2020-01-22. The listed applicant is Ebi, Inc.. The 510(k) number is K190837.

When did Internal Hex Implant System receive FDA 510(k) clearance?

Internal Hex Implant System received FDA 510(k) clearance on 2020-01-22, under 510(k) number K190837.

Who is the listed applicant for Internal Hex Implant System?

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

What is the FDA product code for Internal Hex Implant System?

The FDA product code for Internal Hex Implant System is DZE.

Other records listing Ebi, Inc. 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.

K170031Internal Octa Implant System

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.

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