Cleared Traditional

OKTAGON Implant System

K180360 · Hager& Meisinger GmbH · Dental
May 2018
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K180360 is an FDA 510(k) clearance for the OKTAGON Implant System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Hager& Meisinger GmbH (Neuss, DE). The FDA issued a Cleared decision on May 10, 2018, 90 days after receiving the submission on February 9, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K180360 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2018
Decision Date May 10, 2018
Days to Decision 90 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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