Cleared Traditional

K040143 - MONORAIL

K040143 is an FDA 510(k) clearance for MONORAIL, manufactured by Nats Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K040143 · Nats Corp. · Dental device
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Sep 2004
Decision
235d
Days
Class 2
Risk

K040143 is an FDA 510(k) clearance for the MONORAIL. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nats Corp. (Sound Beach, US). The FDA issued a Cleared decision on September 13, 2004 after a review of 235 days - an extended review 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: 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 Nats Corp. devices

FDA 510(k) Submission Details - K040143

510(k) Number K040143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2004
Decision Date September 13, 2004
Days to Decision 235 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 127d · This submission: 235d
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 1196
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K040143.
AMERICAN DENTAL IMPLANT
K042462 · American Dental Implant Corporation · Sep 2004
THE PRODIGY SYSTEM DENTAL IMPLANTS
K042429 · BioHorizons Implant Systems, Inc. · Sep 2004
MDI ORTHO
K042289 · Imtec Corp. · Sep 2004
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
K041655 · Cowellmedi Co., Ltd. · Sep 2004
ANKYLOS DENTAL IMPLANT SYSTEM
K041509 · Friadent GmbH · Aug 2004
NOBEL BIOCARE ENDOSSEOUS IMPLANTS
K041661 · Nobel Biocare Uas, Inc. · Aug 2004