Skip to content

Life Fast Set, Life Regular Set

by Sybron Dental Specialties

510(k) K150559

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK150559 Date19 Jun 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EJK
Device Class
Class II
Regulation
21 CFR Part 872.3250
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a calcium hydroxide cavity liner, classified as a Class II medical device under regulation number 872.3250. It is intended for use in dental applications as a liner in cavity preparations.

The device was cleared via the FDA 510(k) pathway under K150559, with a decision of substantially equivalent and special clearance type. It is manufactured by Sybron Dental Specialties and supplied as a set containing both Life Fast Set and Life Regular Set formulations.

Other devices from Sybron Dental Specialties, Inc.

  • Prodigy 4

    Class II

  • Kerr Gel Etchant

    Class II

  • Sealapex 4

    Class II

  • Point 4 Flowable

    Class II

  • Temp-Bond Ne 2

    Class II

  • Extrude

    Class II

See all devices from Sybron Dental Specialties, Inc. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Life Fast Set Life Regular Set used for?

    This device is a calcium hydroxide cavity liner intended for use in dental applications as a liner in cavity preparations, providing a protective base under restorative materials.

  • How is the Life Fast Set Life Regular Set supplied?

    The device is supplied as a set containing both Life Fast Set and Life Regular Set formulations, allowing clinicians to choose between setting speeds based on clinical needs.

  • Is the Life Fast Set Life Regular Set sterile or single-use?

    The device data does not specify sterility or single-use status; as a calcium hydroxide liner, it is typically non-sterile and intended for single-patient use during a dental procedure, but reuse is not indicated in the provided information.

  • What sizes or models are available for the Life Fast Set Life Regular Set?

    The device is identified by the name 'Life Fast Set, Life Regular Set' and cleared under K150559; no additional sizes, models, or reference numbers are specified in the provided data beyond this set formulation.

  • How should the Life Fast Set Life Regular Set be stored?

    Storage conditions are not detailed in the device data; however, calcium hydroxide liners are generally stored at room temperature in a dry place, away from direct sunlight, following standard dental material handling practices.