Cleared Traditional

Dental Implants OKTAGON Tissue Level and Bone Level

K162073 · Hager& Meisinger GmbH · Dental
Feb 2017
Decision
212d
Days
Class 2
Risk

About This 510(k) Submission

K162073 is an FDA 510(k) clearance for the Dental Implants OKTAGON Tissue Level and Bone Level, 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 February 24, 2017, 212 days after receiving the submission on July 27, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K162073 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2016
Decision Date February 24, 2017
Days to Decision 212 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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