Cleared Traditional

ZAGA Zygomatic System

K192651 · Southern Implants (Pty), Ltd. · Dental
May 2020
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K192651 is an FDA 510(k) clearance for the ZAGA Zygomatic 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 May 7, 2020, 226 days after receiving the submission on September 24, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K192651 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2019
Decision Date May 07, 2020
Days to Decision 226 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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