Cleared Traditional

K102163 - REALSEAL XT SEALER

K102163 is the FDA 510(k) clearance for REALSEAL XT SEALER by Kerr Corporation. It is a Class 2 Dental device (product code KIF) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K102163 · Kerr Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
75d
Days
Class 2
Risk

K102163 is an FDA 510(k) clearance for the REALSEAL XT SEALER. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on October 16, 2010 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kerr Corporation devices

Submission Details

510(k) Number K102163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2010
Decision Date October 16, 2010
Days to Decision 75 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
52d faster than avg
Panel avg: 127d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 75
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K102163.
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K142178 · Dentsply International, Inc. · Feb 2015
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K060946 · Parkell, Inc. · Jun 2006
ENDOREZ
K042756 · Ultradent Products, Inc. · Oct 2004