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FDA 510(k)

Internal Octa Implant System

K-Number: K170031 · 2017-08-31

ApplicantEbi, Inc.
Decision Date2017-08-31
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Internal Octa Implant System is a medical device manufactured by Ebi, Inc.. It received FDA 510(k) clearance on 2017-08-31 under approval number K170031. 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 Octa Implant System?

Internal Octa Implant System is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Ebi, Inc.. The 510(k) number is K170031.

When was Internal Octa Implant System approved by the FDA?

Internal Octa Implant System received FDA 510(k) clearance on 2017-08-31, under approval number K170031.

What company makes Internal Octa Implant System?

Internal Octa Implant System is manufactured by Ebi, Inc..

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018)

Other Devices by Ebi, Inc.

K190837Internal Hex Implant System

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., 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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