Cleared Traditional

K100248 - DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S

K100248 is an FDA 510(k) clearance for DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, manufactured by Drfp , Ltd.. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K100248 · Drfp , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
268d
Days
Class 2
Risk

K100248 is an FDA 510(k) clearance for the DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Drfp , Ltd. (Amsterdam, Nh, NL). The FDA issued a Cleared decision on October 22, 2010 after a review of 268 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K100248

510(k) Number K100248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2010
Decision Date October 22, 2010
Days to Decision 268 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
140d slower than avg
Panel avg: 128d · This submission: 268d
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 143
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K100248.
MTA ANGELUS
K112046 · Angelus Industria DE Productos Odontologicos · Jan 2012
IROOT FS
K102867 · Innovative Bioceramix, Inc. · Dec 2010
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
K102575 · Do Co., Ltd. · Oct 2010
REALSEAL XT SEALER
K102163 · Kerr Corporation · Oct 2010
SIMPLISEAL
K093208 · Discus Dental, LLC · Feb 2010
BIODENTINE
K092251 · Septodont · Oct 2009
K100248 · DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S
Download PDF FDA Summary Drfp , Ltd.