Cleared Traditional

K971319 - NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES

K971319 is an FDA 510(k) clearance for NT SERIES ENDODONTIC FILES, manufactured by Tycom Dental. The device is a Class 1 Dental device with product code EKS cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K971319 · Tycom Dental · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
42d
Days
Class 1
Risk

K971319 is an FDA 510(k) clearance for the NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES. Classified as File, Pulp Canal, Endodontic (product code EKS), Class I - General Controls.

Submitted by Tycom Dental (San Diego, US). The FDA issued a Cleared decision on May 22, 1997 after a review of 42 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tycom Dental devices

FDA 510(k) Submission Details - K971319

510(k) Number K971319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1997
Decision Date May 22, 1997
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
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 8
Devices cleared under the same product code (EKS) and FDA review panel - the closest regulatory comparables to K971319.
TF ROTARY NICKEL TITANIUM FILE
K062856 · Ormco Corp. · Dec 2006
HERO 642
K970649 · Micro-Mega · May 1997
SHAPING HEDSTROM N.T.
K953604 · Sybron Dental Specialties, Inc. · Sep 1995
DENTAURUM CERAMIC DEBONDING UNIT
K902018 · Dentauraum, Inc. · Apr 1991
VISIONER 21-A
K901037 · J. Morita USA, Inc. · Aug 1990
DENTAL INSTRUMENTS - FILES
K823316 · Miltex, Inc. · Nov 1982