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Modification to: Xive 3.0 Dental Implant System, Multiple

by Friandent GmbH

510(k) K032750

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 · Special NumberK032750 Date2 Oct 2003ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0231-2007 FDA Unclassified (pre-2012) initiated 17 Nov 2006
    • Terminated Z-0230-2007 FDA Unclassified (pre-2012) initiated 17 Nov 2006
    • Terminated Z-0232-2007 FDA Unclassified (pre-2012) initiated 17 Nov 2006

    Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.

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  • Withdrawn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
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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