Cleared Traditional

MEDICON IMF-ORION SCREWS

K050478 · Medicon EG · Dental
Jun 2005
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K050478 is an FDA 510(k) clearance for the MEDICON IMF-ORION SCREWS, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Medicon EG (Tuttlingen, DE). The FDA issued a Cleared decision on June 15, 2005, 111 days after receiving the submission on February 24, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K050478 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2005
Decision Date June 15, 2005
Days to Decision 111 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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