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FDA 510(k)

Deep Conical (DC) Implants and Accessories

K-Number: K163060 · 2017-06-13

ApplicantSouthern Implants (Pty), Ltd.
Decision Date2017-06-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Deep Conical (DC) Implants and Accessories is a medical device manufactured by Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2017-06-13 under approval number K163060. 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 Deep Conical (DC) Implants and Accessories?

Deep Conical (DC) Implants and Accessories is a medical device that received FDA 510(k) clearance on 2017-06-13. It is manufactured by Southern Implants (Pty), Ltd.. The 510(k) number is K163060.

When was Deep Conical (DC) Implants and Accessories approved by the FDA?

Deep Conical (DC) Implants and Accessories received FDA 510(k) clearance on 2017-06-13, under approval number K163060.

What company makes Deep Conical (DC) Implants and Accessories?

Deep Conical (DC) Implants and Accessories is manufactured by Southern Implants (Pty), Ltd..

What is the FDA product code for Deep Conical (DC) Implants and Accessories?

The FDA product code for Deep Conical (DC) Implants and Accessories is DZE.

Related Clinical Trials

NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT07557836 Comparative Clinical Study of Implant Stability and Peri-implant Bone Loss in Two Implant Designs COMPLETED

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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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