Cleared Abbreviated

K041655 - BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)

K041655 is an FDA 510(k) clearance for BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS), manufactured by Cowellmedi Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 82-day FDA review.

K041655 · Cowellmedi Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
82d
Days
Class 2
Risk

K041655 is an FDA 510(k) clearance for the BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Cowellmedi Co., Ltd. (Newington, US). The FDA issued a Cleared decision on September 8, 2004 after a review of 82 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Cowellmedi Co., Ltd. devices

FDA 510(k) Submission Details - K041655

510(k) Number K041655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2004
Decision Date September 08, 2004
Days to Decision 82 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
Pathway characteristics
Standards-based clearance path.

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 759
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K041655.
ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320
K043226 · Imtec Corp. · Jan 2005
THE PRODIGY SYSTEM DENTAL IMPLANTS
K042429 · BioHorizons Implant Systems, Inc. · Sep 2004
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