Cleared Traditional

K153067 - Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153067 · Sybron Dental Specialties · Dental device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 158d · This submission: 279d
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 13
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K153067.
Any-Paste
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