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Eris Layering Materials

by Ivoclar North America, Inc.

510(k) K012174

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 NumberK012174 Date27 Aug 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2265-2015 FDA Class II initiated 9 Jul 2015

    Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.

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  • Withdrawn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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