Cleared Traditional

ELEMENTS OBTURATION UNIT (K031664) - FDA 510(k) Clearance

Class I Dental device.

K031664 · Sybron Endo/Analytic · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
335d
Days
Class 1
Risk

K031664 is an FDA 510(k) clearance for the ELEMENTS OBTURATION UNIT. Classified as Plugger, Root Canal, Endodontic (product code EKR), Class I - General Controls.

Submitted by Sybron Endo/Analytic (Redmond, US). The FDA issued a Cleared decision on April 28, 2004 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sybron Endo/Analytic devices

Submission Details

510(k) Number K031664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2003
Decision Date April 28, 2004
Days to Decision 335 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
208d slower than avg
Panel avg: 127d · This submission: 335d
Pathway characteristics
Predicate-based equivalence.

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.