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LIFE Liner Cavity Calcium Hydroxide

by Sybron Dental Specialties, Inc.

510(k) K944416

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 NumberK944416 Date29 Nov 1994ClearedStatusActive

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  • Withdrawn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)

Full name
Life
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, 6 Oct 2026

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

The LIFE is a dental liner cavity calcium hydroxide device designed for use in dental applications. It is intended to provide a protective barrier in cavities and support dental restorative procedures.

The device is supplied as a single-use product and is not reusable. It is not sterilized and must be handled according to standard dental practices. The device is not MRI safe and should be stored in a dry, cool environment. It is authorized under FDA 510K clearance.

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Questions

AI-generated answers, 6 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 dental liner used for?

    The LIFE is a dental liner cavity calcium hydroxide device designed to provide a protective barrier in cavities and support dental restorative procedures.

  • Is the LIFE device reusable?

    No, the LIFE is a single-use product and is not reusable.

  • How should the LIFE device be stored?

    The LIFE device should be stored in a dry, cool environment.

  • Is the LIFE device sterilized?

    No, the LIFE device is not sterilized and must be handled according to standard dental practices.