Cleared Traditional

NT SWIFT (K004031) - FDA 510(k) Clearance

Also marketed or referenced as:
TI\TEC GATES GLIDDEN DRILLS DENTAL POWER ENDODONTIC HAND FILES

Class I Dental device.

K004031 · Dental Power, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
90d
Days
Class 1
Risk

K004031 is an FDA 510(k) clearance for the NT SWIFT. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by Dental Power, Inc. (Dana Point, US). The FDA issued a Cleared decision on March 28, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 Dental Power, Inc. devices

Submission Details

510(k) Number K004031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2000
Decision Date March 28, 2001
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKS File, Pulp Canal, Endodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.