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510(k) K190503

CeraSeal by Meta Biomed Co., Ltd. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2019
Date Received
March 1, 2019
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

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  • K230009 — EZ Bond Universal (March 3, 2023)
  • K210904 — Metapaste Plus (June 30, 2021)
  • K202617 — Metapex Plus (April 14, 2021)
  • K191991 — Ezfil (March 5, 2020)
  • K190724 — MD-Temp Plus (July 3, 2019)
  • K190510 — GuttaSil (May 29, 2019)
  • K181689 — Nexcomp (November 15, 2018)

Other clearances for product code KIF

  • K253167 — Any-Paste (January 12, 2026)
  • K252890 — ZenSeal Pro (January 7, 2026)
  • 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)