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510(k) K202015

White ENDOSEAL MTA by Maruchi — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2021
Date Received
July 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Root Canal Filling
Device Class
Class II
Regulation Number
872.3820
Review Panel
DE
Submission Type

Other clearances by Maruchi

  • K213757 — Endocem MTA Premixed Regular (February 14, 2023)
  • K212229 — White Endoseal MTA (August 13, 2021)
  • K201799 — CleaniCal (February 12, 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 KIF

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  • K251465 — Root canal repair materials (nRoot BP) (September 25, 2025)
  • K252285 — Well-Root PT (September 19, 2025)
  • K251884 — One-Fil Putty Injectable (August 22, 2025)
  • K251390 — MTA vpt (July 3, 2025)
  • K250710 — Injectable Root Canal Bioceramic Sealer (nRoot SP) (June 11, 2025)
  • K243353 — One-Fil Putty (March 14, 2025)
  • K243546 — AH Plus Endodontic Sealer (February 13, 2025)
  • K242934 — Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (December 12, 2024)