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Elements Obturation Unit

by Sybron Endo/Analytic

510(k) K031664

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 · Traditional NumberK031664 Date28 Apr 2004ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-0413-2018 FDA Class II initiated 27 Dec 2017

    Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).

  • 2 recalls, same reason

    • Terminated Z-1544-2013 FDA Class II initiated 17 Jan 2013
    • Terminated Z-1545-2013 FDA Class II initiated 17 Jan 2013

    A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.

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  • Withdrawn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
EKR
Device Class
Class I
Regulation
21 CFR Part 872.4565
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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