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FDA 510(k)

External Hex Implants

K-Number: K163634 · 2017-11-06

ApplicantSouthern Implants (Pty), Ltd.
Decision Date2017-11-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

External Hex Implants is a medical device manufactured by Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2017-11-06 under approval number K163634. 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 External Hex Implants?

External Hex Implants is a medical device that received FDA 510(k) clearance on 2017-11-06. It is manufactured by Southern Implants (Pty), Ltd.. The 510(k) number is K163634.

When was External Hex Implants approved by the FDA?

External Hex Implants received FDA 510(k) clearance on 2017-11-06, under approval number K163634.

What company makes External Hex Implants?

External Hex Implants is manufactured by Southern Implants (Pty), Ltd..

What is the FDA product code for External Hex Implants?

The FDA product code for External Hex Implants 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.

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