Cleared Traditional

K040143 - MONORAIL

K040143 is the FDA 510(k) clearance for MONORAIL by Nats Corp.. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 594
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K040143.
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K041402 · Implant Innovations, Inc. · Jun 2004