Cleared Abbreviated

OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 (K042828) - FDA 510(k) Clearance

Class I Dental device.

K042828 · Young O/S, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
50d
Days
Class 1
Risk

K042828 is an FDA 510(k) clearance for the OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700. Classified as Plugger, Root Canal, Endodontic (product code EKR), Class I - General Controls.

Submitted by Young O/S, LLC (Fenton, US). The FDA issued a Cleared decision on December 1, 2004 after a review of 50 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Young O/S, LLC devices

Submission Details

510(k) Number K042828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date December 01, 2004
Days to Decision 50 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 127d · This submission: 50d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EKR Plugger, Root 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.