Cleared Special

K150559 - Life Fast Set, Life Regular Set (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K150559 · Sybron Dental Specialties · Dental device
Jun 2015
Decision
105d
Days
Class 2
Risk

K150559 is an FDA 510(k) clearance for the Life Fast Set, Life Regular Set. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Sybron Dental Specialties (Orange, US). The FDA issued a Cleared decision on June 19, 2015 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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.

Submission Details

510(k) Number K150559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2015
Decision Date June 19, 2015
Days to Decision 105 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 158d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
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.