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Ips E.max Cad/Ips E.max Zircad

by Ivoclar Vivadent, Inc.

510(k) K051705

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 ongoing

This device is named in the recall

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 NumberK051705 Date14 Oct 2005ClearedStatusActive

Recalls

10 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-1705-2024 FDA Class II initiated 5 Apr 2024
    • Ongoing Z-1704-2024 FDA Class II initiated 5 Apr 2024
    • Ongoing Z-1707-2024 FDA Class II initiated 5 Apr 2024
    • Ongoing Z-1708-2024 FDA Class II initiated 5 Apr 2024
    • Ongoing Z-1703-2024 FDA Class II initiated 5 Apr 2024
    • Ongoing Z-1706-2024 FDA Class II initiated 5 Apr 2024

    Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration

  • 4 recalls, same reason

    • Terminated Z-1838-2020 FDA Class II initiated 13 Apr 2020
    • Terminated Z-1839-2020 FDA Class II initiated 13 Apr 2020
    • Terminated Z-1837-2020 FDA Class II initiated 13 Apr 2020
    • Terminated Z-1840-2020 FDA Class II initiated 13 Apr 2020

    Restorations crack during the sintering process.

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  • Withdrawn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

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