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FDA 510(k)

EBI INTERNAL IMPLANT SYSTEM

K-Number: K073116 · 2008-02-28

ApplicantEbi, Inc.
Decision Date2008-02-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EBI INTERNAL 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 2008-02-28 under 510(k) number K073116. 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 EBI INTERNAL IMPLANT SYSTEM?

EBI INTERNAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-28. The listed applicant is Ebi, Inc.. The 510(k) number is K073116.

When did EBI INTERNAL IMPLANT SYSTEM receive FDA 510(k) clearance?

EBI INTERNAL IMPLANT SYSTEM received FDA 510(k) clearance on 2008-02-28, under 510(k) number K073116.

Who is the listed applicant for EBI INTERNAL 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 EBI INTERNAL IMPLANT SYSTEM?

The FDA product code for EBI INTERNAL IMPLANT SYSTEM is DZE.

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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.

K190837Internal Hex Implant SystemK170031Internal 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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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