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510(k) K221811

Vista BC Sealer by Inter-Med, Inc. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2022
Date Received
June 22, 2022
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 Inter-Med, Inc.

  • K241489 — ReminGel (January 8, 2025)
  • K241457 — Vista BC Putty (August 28, 2024)
  • K241354 — Sealer Solvent (August 27, 2024)
  • K211721 — PS System (December 2, 2021)
  • K112250 — CHX=CHX PLUS (October 28, 2011)
  • K082470 — SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE (April 3, 2009)
  • K871291 — AM CATH ESWL STENT (April 30, 1987)
  • K864669 — AM CATH ESWL STENT (January 5, 1987)
  • K851922 — URETERAL STONE DISLODGER (August 2, 1985)
  • K833058 — GEN. PURPOSE INSTRUMENT TRAYS & (January 31, 1984)

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)