Cleared Traditional

K023819 - FIBERFILL SGP

K023819 is an FDA 510(k) clearance for FIBERFILL SGP, manufactured by Pentron Clinical Technologies. The device is a Class 1 Dental device with product code EKM cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K023819 · Pentron Clinical Technologies · Dental device
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Mar 2003
Decision
131d
Days
Class 1
Risk

K023819 is an FDA 510(k) clearance for the FIBERFILL SGP. Classified as Gutta-percha (product code EKM), Class I - General Controls.

Submitted by Pentron Clinical Technologies (Wallingford, US). The FDA issued a Cleared decision on March 26, 2003 after a review of 131 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Pentron Clinical Technologies devices

FDA 510(k) Submission Details - K023819

510(k) Number K023819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2002
Decision Date March 26, 2003
Days to Decision 131 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 127d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

EKM Device Classification - Class 1, General Controls

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.