Cleared Traditional

External Hex Implants

K163634 · Southern Implants (Pty), Ltd. · Dental
Nov 2017
Decision
319d
Days
Class 2
Risk

About This 510(k) Submission

K163634 is an FDA 510(k) clearance for the External Hex Implants, 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 November 6, 2017, 319 days after receiving the submission on December 22, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K163634 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2016
Decision Date November 06, 2017
Days to Decision 319 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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