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510(k) K240446

Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + by Shiva Products — Product Code KIF

K240446 is an FDA 510(k) premarket notification submitted by Shiva Products for the device "Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +". The FDA issued a decision of Substantially Equivalent on July 30, 2024. The device falls under product code KIF (Resin, Root Canal Filling), a Class II device regulated under 21 CFR 872.3820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2024
Date Received
February 15, 2024
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 for product code KIF

  • K262050 — Vioseal X (September 11, 2026)
  • K253909 — NeoPEX™ Pre-Mixed Obturation Paste (September 4, 2026)
  • K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal) (August 25, 2026)
  • K261415 — Injectable Root Canal Sealer (KP-Root SP) (June 29, 2026)
  • 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)

FDA data resources