Cleared Traditional

K153067 - Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress

K153067 is an FDA 510(k) clearance for Tubli-Seal, manufactured by Sybron Dental Specialties. The device is a Class 2 Dental device with product code KIF cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K153067 · Sybron Dental Specialties · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
279d
Days
Class 2
Risk

K153067 is an FDA 510(k) clearance for the Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress. 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 July 27, 2016 after a review of 279 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 Sybron Dental Specialties devices

FDA 510(k) Submission Details - K153067

510(k) Number K153067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2015
Decision Date July 27, 2016
Days to Decision 279 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
152d slower than avg
Panel avg: 127d · This submission: 279d
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 K153067.
SavDenTM MTA Root Canal Filling Materials
K162661 · Tyds Biotech Incorporation · Apr 2017
MTA2.2 MATERIAL
K161239 · Avalon Biomed, Inc. · Sep 2016
MTA Repair HP
K151047 · Angelus Industria DE Productos Odontologicos · Aug 2016
Pulp Canal Sealer, Pulp Canal Sealer EWT
K152956 · Sybron Dental Specialties · May 2016
Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes
K152959 · Sybron Dental Specialties · Apr 2016
PROROOT MTA WHITE, PROROOT MTA GRAY
K142178 · Dentsply International, Inc. · Feb 2015