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Herculite Ultra

by Sybron Dental Specialties

510(k) K082671

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 NumberK082671 Date11 Dec 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0916-2010 FDA Unclassified (pre-2012) initiated 23 Feb 2009

    Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card.

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  • Withdrawn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
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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