Cleared Special

K150559 - Life Fast Set, Life Regular Set

K150559 is an FDA 510(k) clearance for Life Fast Set, manufactured by Sybron Dental Specialties. The device is a Class 2 Dental device with product code EJK cleared through the Special 510(k) pathway after a 105-day FDA review.

K150559 · Sybron Dental Specialties · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Sybron Dental Specialties devices

FDA 510(k) Submission Details - K150559

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

EJK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - EJK Liner, Cavity, Calcium Hydroxide

All 60
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K150559.
Parkell Desensitizer Gel
K191103 · Parkell, Inc. · Nov 2019
TheraCal DC
K180344 · Bisco, Inc. · Apr 2018
TheraCal DC
K143292 · Bisco, Inc. · Aug 2015
LC CALCIUMHYDROXIDE LINER
K141047 · S&C Polymer Silicon- Und Composite Spezialitaeten · Apr 2015
BASE IT
K134022 · Spident Co., Ltd. · Jun 2014
TEETHMATE DESENSITIZER SET
K131068 · Kuraray Noritake Dental, Inc. · Aug 2013