Cleared Traditional

K041527 - AARHUS ANCHORAGE SYSTEM

K041527 is an FDA 510(k) clearance for AARHUS ANCHORAGE SYSTEM, 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 72-day FDA review.

K041527 · Medicon EG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
72d
Days
Class 2
Risk

K041527 is an FDA 510(k) clearance for the AARHUS ANCHORAGE SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Medicon EG (Orange, US). The FDA issued a Cleared decision on August 19, 2004 after a review of 72 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medicon EG devices

FDA 510(k) Submission Details - K041527

510(k) Number K041527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2004
Decision Date August 19, 2004
Days to Decision 72 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
55d faster than avg
Panel avg: 127d · This submission: 72d
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 K041527.
MDI ORTHO
K042289 · Imtec Corp. · Sep 2004
NOBEL BIOCARE ENDOSSEOUS IMPLANTS
K041661 · Nobel Biocare Uas, Inc. · Aug 2004
NOBELDIRECT OD IMPLANT
K041876 · Nobel Biocare Uas, Inc. · Aug 2004
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K041492 · Astra Tech, Inc. · Aug 2004
DENTIUM CO., LTD. IMPLANTIUM
K041368 · Dentium Co., Ltd. · Jul 2004
ACE CONNECT INTERNAL CONNECTION
K041759 · Ace Surgical Supply Co., Inc. · Jul 2004