Cleared Traditional

External Hex Implant System

K232726 · Southern Implants (Pty), Ltd. · Dental
Apr 2024
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K232726 is an FDA 510(k) clearance for the External Hex Implant System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Southern Implants (Pty), Ltd. (Guateng, ZA). The FDA issued a Cleared decision on April 1, 2024, 208 days after receiving the submission on September 6, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K232726 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2023
Decision Date April 01, 2024
Days to Decision 208 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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