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Spectra System

by Implant Direct, LLC

510(k) K061319

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 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 NumberK061319 Date29 Sep 2006ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0010-2020 FDA Class II initiated 7 Aug 2018

    The incorrect device was packaged in the vial.

    • Terminated Z-2376-2018 FDA Class II initiated 18 May 2018

    Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant

    • Terminated Z-2125-2017 FDA Class II initiated 2 May 2017

    Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.

    • Terminated Z-2320-2016 FDA Class II initiated 5 Jul 2016

    Issue with design specification; oversized condition.

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  • Withdrawn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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