Cleared Traditional

K120048 - DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S

K120048 is an FDA 510(k) clearance for DRFP PROPOINTS, 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 166-day FDA review.

K120048 · Drfp , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
166d
Days
Class 2
Risk

K120048 is an FDA 510(k) clearance for the DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Drfp , Ltd. (Amsterdam, GB). The FDA issued a Cleared decision on June 20, 2012 after a review of 166 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.

View all Drfp , Ltd. devices

FDA 510(k) Submission Details - K120048

510(k) Number K120048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2012
Decision Date June 20, 2012
Days to Decision 166 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
39d slower than avg
Panel avg: 127d · This submission: 166d
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 93
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K120048.
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