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Zone, ZoneFree, Zone A1

by Sybron Dental Specialties

510(k) K151526

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 NumberK151526 Date10 Sep 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  • Withdrawn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
EMA
Device Class
Class II
Regulation
21 CFR Part 872.3275
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.

The Zone, ZoneFree, Zone A1 is a Zinc Oxide Non-Eugenol temporary dental cement, consisting of a catalyst paste containing Zinc Oxide and a base paste containing Dimer Acid. It is used for temporary restoration cementation and sets through a self-cure reaction between its components. This device is classified as a dental cement. The device is used by licensed dental professionals in clinical settings for temporary restoration cementation, typically for up to 30 days.

The Zone, ZoneFree, Zone A1 is supplied as a temporary dental cement and is regulated under FDA class 2, with a regulation number of 872.3275. It has been cleared through the traditional 510(k) clearance process, with a decision of Substantially Equivalent. The device has a product code of EMA and is intended for use in dental applications.

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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 Zone Temporary Dental Cement used for?

    The Zone Temporary Dental Cement is used for temporary restoration cementation, typically for up to 30 days, by licensed dental professionals in clinical settings.

  • How is the Zone Temporary Dental Cement supplied?

    The Zone Temporary Dental Cement is supplied as a temporary dental cement, consisting of a catalyst paste and a base paste, and is regulated under FDA class 2.

  • Is the Zone Temporary Dental Cement a single-use or reusable device?

    The Zone Temporary Dental Cement is intended for temporary use, but its reuse or single-use status is not explicitly stated, and its handling should follow standard dental cement protocols.

  • What are the key components of the Zone Temporary Dental Cement?

    The Zone Temporary Dental Cement consists of a catalyst paste containing Zinc Oxide and a base paste containing Dimer Acid, which set through a self-cure reaction.