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Tempbond Clear-2

by Sybron Dental Specialties, Inc.

510(k) K982590

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK982590 Date8 Oct 1998ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0074-2010 FDA Unclassified (pre-2012) initiated 9 Sep 2009

    The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.

    • Terminated Z-1524-06 FDA Unclassified (pre-2012) initiated 14 Aug 2006

    Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured)

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  • Withdrawn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
EMA
Device Class
Class II
Regulation
21 CFR Part 872.3275
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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