Cleared Traditional

Dental Implants OKTAGON Bone Level Tapered Design

K170287 · Hager& Meisinger GmbH · Dental
May 2017
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K170287 is an FDA 510(k) clearance for the Dental Implants OKTAGON Bone Level Tapered Design, 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 24, 2017, 114 days after receiving the submission on January 30, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K170287 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2017
Decision Date May 24, 2017
Days to Decision 114 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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