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Lava Ultimate Cad/Cam Restorative for Cerec / E4D, Lava Ultimate Implant Crown Restorative

by 3M Espe Dental Products

510(k) K110131

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK110131 Date21 Jan 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2052-2015 FDA Class II initiated 15 Jun 2015

    3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. These products will continue to be indicated for onlays, inlays and veneers.

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  • Withdrawn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
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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