Cleared Special

K152959 - Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes

K152959 is an FDA 510(k) clearance for Sealapex tubes, manufactured by Sybron Dental Specialties. The device is a Class 2 Dental device with product code KIF cleared through the Special 510(k) pathway after a 190-day FDA review.

K152959 · Sybron Dental Specialties · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
190d
Days
Class 2
Risk

K152959 is an FDA 510(k) clearance for the Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Sybron Dental Specialties (Orange, US). The FDA issued a Cleared decision on April 14, 2016 after a review of 190 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sybron Dental Specialties devices

FDA 510(k) Submission Details - K152959

510(k) Number K152959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2015
Decision Date April 14, 2016
Days to Decision 190 days
Submission Type Special
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
63d slower than avg
Panel avg: 127d · This submission: 190d
Pathway characteristics
Modification to existing cleared device.

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 K152959.
MTA Repair HP
K151047 · Angelus Industria DE Productos Odontologicos · Aug 2016
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
K153067 · Sybron Dental Specialties · Jul 2016
Pulp Canal Sealer, Pulp Canal Sealer EWT
K152956 · Sybron Dental Specialties · May 2016
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178 · Dentsply International, Inc. · Feb 2015
IROOT FM
K130312 · Innovative Bioceramix, Inc. · Sep 2014
BIODENTINE
K140132 · Septodont · Jun 2014