FDA 510(k)

MINICONE Implant

K-Number: K200906 · 2020-10-16

Decision Date2020-10-16

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

MINICONE Implant is a medical device manufactured by Medentika GmbH. It received FDA 510(k) clearance on 2020-10-16 under approval number K200906. 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 MINICONE Implant?

MINICONE Implant is a medical device that received FDA 510(k) clearance on 2020-10-16. It is manufactured by Medentika GmbH. The 510(k) number is K200906.

When was MINICONE Implant approved by the FDA?

MINICONE Implant received FDA 510(k) clearance on 2020-10-16, under approval number K200906.

What company makes MINICONE Implant?

MINICONE Implant is manufactured by Medentika GmbH.

What is the FDA product code for MINICONE Implant?

The FDA product code for MINICONE Implant is DZE.

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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.