Cleared Traditional

Dental Implant OKTAGON Bone Level

K143539 · Hager& Meisinger GmbH · Dental
Aug 2015
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K143539 is an FDA 510(k) clearance for the Dental Implant OKTAGON 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 August 31, 2015, 259 days after receiving the submission on December 15, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K143539 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2014
Decision Date August 31, 2015
Days to Decision 259 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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