Cleared Traditional

K102163 - REALSEAL XT SEALER

K102163 is an FDA 510(k) clearance for REALSEAL XT SEALER, manufactured by Kerr Corporation. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K102163

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
Combination Product No
PCCP Authorized No
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.

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 124
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K102163.
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S
K120048 · Drfp , Ltd. · Jun 2012
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)
K112078 · Maruchi · Mar 2012
MTA ANGELUS
K112046 · Angelus Industria DE Productos Odontologicos · Jan 2012
WELL-PASTE
K090992 · Vericom Co., Ltd. · Apr 2009
ROOT CANAL XR
K083062 · S & C Polymer GmbH · Mar 2009
WELL-PEX
K080266 · Vericom Co., Ltd. · Feb 2008