FDA 510(k)

Inversa Implants

K-Number: K181850 · 2018-11-14

Decision Date2018-11-14

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Inversa Implants is a medical device manufactured by Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2018-11-14 under approval number K181850. 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 Inversa Implants?

Inversa Implants is a medical device that received FDA 510(k) clearance on 2018-11-14. It is manufactured by Southern Implants (Pty), Ltd.. The 510(k) number is K181850.

When was Inversa Implants approved by the FDA?

Inversa Implants received FDA 510(k) clearance on 2018-11-14, under approval number K181850.

What company makes Inversa Implants?

Inversa Implants is manufactured by Southern Implants (Pty), Ltd..

What is the FDA product code for Inversa Implants?

The FDA product code for Inversa Implants is DZE.

Other Devices by Southern Implants (Pty), Ltd.

K161548Osseointegrated Fixtures K163634External Hex Implants K163060Deep Conical (DC) Implants and Accessories K180465Provata Implant System K173706Piccolo Implants and Accessories K173343Zygomatic Implant System

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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.