Home / 510(k) Clearances / K250156

510(k) K250156

Choice 2 DC by Bisco, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2025
Date Received
January 21, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Bisco, Inc.

  • 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)
  • K143292 — TheraCal DC (August 4, 2015)

Other clearances for product code EMA

  • K254063 — iCEM Universal Plus (December 19, 2025)
  • K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement (December 12, 2025)
  • K252808 — GlasIonomer FX-LC (December 9, 2025)
  • K252165 — ZIRCONOMER P (October 28, 2025)
  • K250953 — EQUIA LC ONE (September 19, 2025)
  • K251775 — RODIN Cement (September 2, 2025)
  • K251470 — ResiCem EX (July 11, 2025)
  • K250566 — EsCem RMGI (June 20, 2025)
  • K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abut (January 10, 2025)
  • K240714 — Insure® Universal; Insure® Universal Automix (July 24, 2024)