Home / 510(k) Clearances / K240735

510(k) K240735

visio.lign color, visio.lign shield by Bredent GmbH & Co. KG — Product Code EBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2024
Date Received
March 18, 2024
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 Bredent GmbH & Co. KG

  • K152113 — BioHPP - breCAM.BioHPP (July 21, 2016)
  • K101064 — BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P (September 14, 2010)

Other clearances for product code EBD

  • K250804 — ID LIGHT CURE SYSTEM (June 4, 2025)
  • 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)
  • K080549 — DURAFINISH ALL-CURE, MODEL S296 (May 13, 2008)