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510(k) K180344

TheraCal DC by Bisco, Inc. — Product Code EJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2018
Date Received
February 8, 2018
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liner, Cavity, Calcium Hydroxide
Device Class
Class II
Regulation Number
872.3250
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)
  • 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 EJK

  • K253248 — Bright Cavity Liner (January 13, 2026)
  • K230270 — 3M™ VitCal Liner/Base (February 6, 2023)
  • K212475 — Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) (May 13, 2022)
  • K201799 — CleaniCal (February 12, 2021)
  • K202413 — LC ResinCal PC (November 20, 2020)
  • K191103 — Parkell Desensitizer Gel (November 22, 2019)
  • K143292 — TheraCal DC (August 4, 2015)
  • K150559 — Life Fast Set, Life Regular Set (June 19, 2015)
  • K141047 — LC CALCIUMHYDROXIDE LINER (April 14, 2015)
  • K134022 — BASE IT (June 11, 2014)