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510(k) K201799

CleaniCal by Maruchi — Product Code EJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2021
Date Received
June 30, 2020
Clearance Type
Traditional
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 Maruchi

  • K213757 — Endocem MTA Premixed Regular (February 14, 2023)
  • K212229 — White Endoseal MTA (August 13, 2021)
  • K202015 — White ENDOSEAL MTA (March 24, 2021)
  • K170175 — ENDOSEAL MTA (February 26, 2018)
  • K133042 — ENDOCEM ZR (May 12, 2014)
  • K133054 — ENDOSEAL (May 12, 2014)
  • K112078 — ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) (March 19, 2012)

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)
  • K202413 — LC ResinCal PC (November 20, 2020)
  • K191103 — Parkell Desensitizer Gel (November 22, 2019)
  • K180344 — TheraCal DC (April 5, 2018)
  • 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)