Cleared Traditional

K050478 - MEDICON IMF-ORION SCREWS

K050478 is an FDA 510(k) clearance for MEDICON IMF-ORION SCREWS, manufactured by Medicon EG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K050478 · Medicon EG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
111d
Days
Class 2
Risk

K050478 is an FDA 510(k) clearance for the MEDICON IMF-ORION SCREWS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Medicon EG (Tuttlingen, DE). The FDA issued a Cleared decision on June 15, 2005 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Medicon EG devices

FDA 510(k) Submission Details - K050478

510(k) Number K050478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 821
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K050478.
3I OSSEOTITE DENTAL IMPLANTS
K051461 · Implant Innovations, Inc. · Sep 2005
PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS
K051614 · Lifecore Biomedical, Inc. · Sep 2005
SPI DENTAL IMPLANT
K051502 · Thommen Medical AG · Jun 2005
NOBELSPEEDY IMPLANTS
K050406 · Nobel Biocare AB · Jun 2005
PREVAIL DENTAL IMPLANTS
K051189 · Implant Innovations, Inc. · Jun 2005
TIUNITE IMPLANTS
K050705 · Nobel Biocare AB · May 2005