Helioseal

• • Terminated Z-1026-2016 FDA Class II ·initiated 12 Feb 2016

  Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.

510(k) Number

K813015 ↗

FDA Product Code

EBC

Device Class

Class II

Regulation

21 CFR Part 872.3765

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Heliobond

  Class II

  FDA 510(k) K802681 Active Cleared 24 Nov 1980

• Contact Resin

  Class II

  FDA 510(k) K790439 Active Cleared 10 Apr 1979

• Colorant

  Class II

  FDA 510(k) K790438 Active Cleared 10 Apr 1979

• Bondalcap (Silico-Phosphate)

  Class II

  FDA 510(k) K801228 Active Cleared 4 Jun 1980

• Heliosit

  Class II

  FDA 510(k) K802683 Active Cleared 24 Nov 1980

• Silanit

  Class II

  FDA 510(k) K802679 Active Cleared 17 Dec 1980

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