Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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 2017-11-06 under 510(k) 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. The listed applicant is Southern Implants (Pty), Ltd.. The 510(k) number is K163634.

When did External Hex Implants receive FDA 510(k) clearance?

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

Who is the listed applicant for External Hex Implants?

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 External Hex Implants?

The FDA product code for External Hex Implants 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.

K232726External Hex Implant SystemK232418Single Platform SP1 Implant SystemK230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsK222469TIB AbutmentsK222457Provata Implant SystemK222497Zaga Zygomatic System

View all 19 devices →

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.

↑