Cleared Traditional

DENTAL IMPLANT SYSTEM

K122807 · Hager& Meisinger GmbH · Dental
Jun 2014
Decision
652d
Days
Class 2
Risk

About This 510(k) Submission

K122807 is an FDA 510(k) clearance for the DENTAL IMPLANT SYSTEM, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Hager& Meisinger GmbH (Centennial, US). The FDA issued a Cleared decision on June 13, 2014, 652 days after receiving the submission on August 30, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K122807 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2012
Decision Date June 13, 2014
Days to Decision 652 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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