Cleared Traditional

MyPlant II Implant System

K173819 · Hager& Meisinger GmbH · Dental
Aug 2018
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K173819 is an FDA 510(k) clearance for the MyPlant II 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 August 9, 2018, 234 days after receiving the submission on December 18, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K173819 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2017
Decision Date August 09, 2018
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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