Home / 510(k) Clearances / K051999

510(k) K051999

BISCOVER LED by Bisco, Inc. — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2005
Date Received
July 25, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Filling Material, Resin
Device Class
Class II
Regulation Number
872.3310
Review Panel
DE
Submission Type

Other clearances by Bisco, Inc.

  • K250156 — Choice 2 DC (July 11, 2025)
  • K242816 — Quantium (December 17, 2024)
  • K192007 — TheraBase, TheraBase Ca (March 17, 2020)
  • K182917 — FluoroCal (November 18, 2019)
  • K180344 — TheraCal DC (April 5, 2018)
  • K171147 — REVEAL Bulk (August 4, 2017)
  • K162598 — HAPI Seal (May 23, 2017)
  • K163171 — CeraClean (April 14, 2017)
  • K161051 — All-Bond Universal w/BAC (not finalized) (September 9, 2016)
  • K161256 — TheraCem (July 29, 2016)

Other clearances for product code EBD

  • K250804 — ID LIGHT CURE SYSTEM (June 4, 2025)
  • K240735 — visio.lign color, visio.lign shield (December 12, 2024)
  • K223365 — RODIN Palette Naturalizing Kit (March 27, 2023)
  • K211854 — VITA Akzent LC (November 22, 2021)
  • K162408 — Nano Varnish, Plaquit, Lightpaint on Surface (April 5, 2018)
  • K163568 — SHOFU RESIN GLAZE (August 16, 2017)
  • K133836 — OPTIGLAZE COLOR (March 6, 2014)
  • K123761 — VITA ENAMIC STAINS (March 1, 2013)
  • K093019 — ENAMELITE ACRYSEAL SPRAY SEALANT (December 22, 2009)
  • K082285 — EASY GLAZE (October 24, 2008)