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FDA 510(k)

Provata Implant System

K-Number: K180465 · 2018-09-06

ApplicantSouthern Implants (Pty), Ltd.
Decision Date2018-09-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Provata Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Southern Implants (Pty), Ltd.. It received FDA 510(k) clearance on 2018-09-06 under 510(k) number K180465. 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 Provata Implant System?

Provata Implant System is a medical device that received FDA 510(k) clearance on 2018-09-06. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K180465.

When did Provata Implant System receive FDA 510(k) clearance?

Provata Implant System received FDA 510(k) clearance on 2018-09-06, under 510(k) number K180465.

Who is the listed applicant for Provata Implant System?

The FDA 510(k) record lists Southern Implants (Pty), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Provata Implant System?

The FDA product code for Provata Implant System is DZE.

Other records listing Southern Implants (Pty), Ltd. as applicant

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , 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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