Cleared Traditional

EASY X-TRAC SYSTEM (K060691) - FDA 510(k) Clearance

Class I Dental device.

K060691 · A. Titan Instruments, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
89d
Days
Class 1
Risk

K060691 is an FDA 510(k) clearance for the EASY X-TRAC SYSTEM. Classified as Forceps, Tooth Extractor, Surgical (product code EMG), Class I - General Controls.

Submitted by A. Titan Instruments, Inc. (Hamburg, US). The FDA issued a Cleared decision on June 12, 2006 after a review of 89 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 A. Titan Instruments, Inc. devices

Submission Details

510(k) Number K060691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2006
Decision Date June 12, 2006
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMG Forceps, Tooth Extractor, Surgical
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.