Cleared Traditional

Single Platform SP1 Implant System

K232418 · Southern Implants (Pty), Ltd. · Dental
Dec 2023
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K232418 is an FDA 510(k) clearance for the Single Platform SP1 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 1, 2023, 112 days after receiving the submission on August 11, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K232418 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2023
Decision Date December 01, 2023
Days to Decision 112 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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