Cleared Traditional

K073369 - EI DOWNPAK BARRIER SLEEVES (FDA 510(k) Clearance)

Class I Dental device.

K073369 · Hu-Friedy Mfg. Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
89d
Days
Class 1
Risk

K073369 is an FDA 510(k) clearance for the EI DOWNPAK BARRIER SLEEVES. Classified as Gutta-percha (product code EKM), Class I - General Controls.

Submitted by Hu-Friedy Mfg. Co., Inc. (Chicago, US). The FDA issued a Cleared decision on February 27, 2008 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3850 - 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 Hu-Friedy Mfg. Co., Inc. devices

Submission Details

510(k) Number K073369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2007
Decision Date February 27, 2008
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 EKM Gutta-percha
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3850
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.