Cleared Traditional

K023818 - FIBERFILL AGP

K023818 is an FDA 510(k) clearance for FIBERFILL AGP, manufactured by Pentron Clinical Technologies. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K023818 · Pentron Clinical Technologies · Dental device
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Apr 2003
Decision
139d
Days
Class 2
Risk

K023818 is an FDA 510(k) clearance for the FIBERFILL AGP. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Pentron Clinical Technologies (Wallingford, US). The FDA issued a Cleared decision on April 3, 2003 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - 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 - K023818

510(k) Number K023818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2002
Decision Date April 03, 2003
Days to Decision 139 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
12d slower than avg
Panel avg: 127d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KIF Device Classification - Class 2, Special Controls

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KIF Resin, Root Canal Filling

All 97
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K023818.
DIAPEX
K033585 · Bisco, Inc. · Jan 2004
METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING
K032605 · Meta Biomed Co., Ltd. · Oct 2003
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
K032603 · Meta Biomed Co., Ltd. · Oct 2003
PULPDENT CALCIUM HYDROXIDE PREPARATION
K022734 · Pulpdent Corporation · Oct 2002
FIRST FILL R.C.S.
K011748 · Jeneric/Pentron, Inc. · Aug 2001
SEALAPEX 4
K010940 · Sybron Dental Specialties, Inc. · Jun 2001