Cleared Traditional

Zygomatic Implant System

K173343 · Southern Implants (Pty), Ltd. · Dental
Feb 2018
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K173343 is an FDA 510(k) clearance for the Zygomatic 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 February 27, 2018, 126 days after receiving the submission on October 24, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K173343 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2017
Decision Date February 27, 2018
Days to Decision 126 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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