Cleared Traditional

K004031 - NT SWIFT

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

K004031 is an FDA 510(k) clearance for NT SWIFT, manufactured by Dental Power, Inc.. The device is a Class 1 Dental device with product code EKS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K004031

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.

EKS Device Classification - Class 1, General Controls

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.

Regulatory Peers - EKS File, Pulp Canal, Endodontic

All 10
Devices cleared under the same product code (EKS) and FDA review panel - the closest regulatory comparables to K004031.
TF ROTARY NICKEL TITANIUM FILE
K062856 · Ormco Corp. · Dec 2006
NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES
K971319 · Tycom Dental · May 1997
HERO 642
K970649 · Micro-Mega · May 1997
QUANTEC SERIES 2000 ENDODONTIC FILES
K962031 · Tycom Dental · Jun 1996
SHAPING HEDSTROM N.T.
K953604 · Sybron Dental Specialties, Inc. · Sep 1995
DENTAURUM CERAMIC DEBONDING UNIT
K902018 · Dentauraum, Inc. · Apr 1991