Skip to content

Zenostar MT, Zenostar Color Liquids

by Wieland Dental + Technik GmbH & Co. KG

510(k) K152118

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

21 closed

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 NumberK152118 Date16 Dec 2015ClearedStatusActive

Recalls

21 recalls · FDA

  • 21 recalls, same reason

    • Terminated Z-0018-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0029-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0032-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0027-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0021-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0025-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0033-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0023-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0024-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0030-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0017-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0035-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0031-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0020-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0019-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0026-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0034-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0037-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0022-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0036-2017 FDA Class II initiated 27 May 2016
    • Terminated Z-0028-2017 FDA Class II initiated 27 May 2016

    The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.

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  • Withdrawn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
EIH
Device Class
Class II
Regulation
21 CFR Part 872.6660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Wieland Dental + Technik GmbH & Co. KG

See all devices from Wieland Dental + Technik GmbH & Co. KG →