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) Official FDA 510(k) Summary (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.

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
23d faster than avg
Panel avg: 128d · 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 77
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
K150559 · Life Fast Set, Life Regular Set
Download PDF FDA Summary Sybron Dental Special…