Cleared Traditional

Southern Implants MAX Implant System

K191054 · Southern Implants (Pty), Ltd. · Dental
Dec 2019
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K191054 is an FDA 510(k) clearance for the Southern Implants MAX 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 December 9, 2019, 234 days after receiving the submission on April 19, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K191054 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2019
Decision Date December 09, 2019
Days to Decision 234 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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