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Helioseal F

by Ivoclar North America, Inc.

510(k) K932078

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 NumberK932078 Date15 Sep 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0213-2016 FDA Class II initiated 7 Oct 2015

    A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty component seem to be larger than the size defined in the formula. This results in difficulties during extrusion of the material.

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  • Withdrawn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
EBC
Device Class
Class II
Regulation
21 CFR Part 872.3765
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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