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) Official FDA 510(k) Summary (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.

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
62d slower than avg
Panel avg: 128d · 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 146
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K152959.
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BIODENTINE
K140132 · Septodont · Jun 2014
K152959 · Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
Download PDF FDA Summary Sybron Dental Special…