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Life and Life Fast Set

by Sybron Dental Specialties, Inc.

510(k) K961708

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 · Traditional NumberK961708 Date30 May 1996ClearedStatusActive

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  • Withdrawn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, 1 Oct 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 Liner, Cavity, Calcium Hydroxide, as defined in the FDA classification system. It is intended for use in dental applications.

It was cleared via the FDA 510(k) process under K961708, with product code EJK and regulation number 872.3250. The device is classified as Class II and is manufactured by Sybron Dental Specialties, Inc. in Orange, California.

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Questions

AI-generated answers, 1 Oct 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 AND LIFE FAST SET used for?

    The LIFE AND LIFE FAST SET is a dental liner composed of calcium hydroxide, intended for use in cavity applications to protect the pulp and support restorative materials in dental procedures.

  • How is the LIFE AND LIFE FAST SET supplied and is it sterile?

    The device data does not specify the supply format or sterility status of the LIFE AND LIFE FAST SET; therefore, no information about its packaging, delivery form, or sterilization method can be provided based on the available details.

  • Is the LIFE AND LIFE FAST SET reusable or single-use?

    The provided device information does not indicate whether the LIFE AND LIFE FAST SET is designed for single-use or reuse, so no determination about its reusability can be made from the data given.