Cleared Traditional

Inversa Implants

K181850 · Southern Implants (Pty), Ltd. · Dental
Nov 2018
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K181850 is an FDA 510(k) clearance for the Inversa 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 14, 2018, 126 days after receiving the submission on July 11, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K181850 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2018
Decision Date November 14, 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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