Cleared Traditional

K052369 - EXFEEL IMPLANT SYSTEM

K052369 is an FDA 510(k) clearance for EXFEEL IMPLANT SYSTEM, manufactured by Megagen Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K052369 · Megagen Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
134d
Days
Class 2
Risk

K052369 is an FDA 510(k) clearance for the EXFEEL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Megagen Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on January 10, 2006 after a review of 134 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.

FDA 510(k) Submission Details - K052369

510(k) Number K052369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2005
Decision Date January 10, 2006
Days to Decision 134 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 128d · This submission: 134d
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 1483
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K052369.
KLOCKNER DENTAL IMPLANT, MODEL S3M
K052654 · SOADCO, S.L. · Jan 2006
ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM
K052951 · Innova Life Sciences Corp. · Jan 2006
ZIMMER DENTAL ONE-PIECE IMPLANT
K052997 · Zimmer Dental, Inc. · Jan 2006
PITT-EASY DENTAL IMPLANT SYSTEM
K053242 · Innova Life Sciences Corp. · Jan 2006
HDC SPIDER SCREW
K052471 · Hdc S.R.L. · Dec 2005
ALMITECH INC. DENTAL IMPLANT SYSTEM
K052733 · Almitech, Inc. · Dec 2005
K052369 · EXFEEL IMPLANT SYSTEM
Download PDF FDA Summary Megagen Co., Ltd.