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FDA 510(k)

Single Platform SP1 Implant System

K-Number: K232418 · 2023-12-01

ApplicantSouthern Implants (Pty), Ltd.
Decision Date2023-12-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Single Platform SP1 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 2023-12-01 under 510(k) number K232418. 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 Single Platform SP1 Implant System?

Single Platform SP1 Implant System is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K232418.

When did Single Platform SP1 Implant System receive FDA 510(k) clearance?

Single Platform SP1 Implant System received FDA 510(k) clearance on 2023-12-01, under 510(k) number K232418.

Who is the listed applicant for Single Platform SP1 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 Single Platform SP1 Implant System?

The FDA product code for Single Platform SP1 Implant System is DZE.

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

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.

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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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