KIF — Resin, Root Canal Filling Class II

FDA Device Classification

Classification Details

Product Code
KIF
Device Class
Class II
Regulation Number
872.3820
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253167mediclus coAny-PasteJanuary 12, 2026
K252890kerr corporationZenSeal ProJanuary 7, 2026
K251465enpuno biotechnology coRoot canal repair materials (nRoot BP)September 25, 2025
K252285vericom coWell-Root PTSeptember 19, 2025
K251884mediclus coOne-Fil Putty InjectableAugust 22, 2025
K251390vocoMTA vptJuly 3, 2025
K250710enpuno coInjectable Root Canal Bioceramic Sealer (nRoot SP)June 11, 2025
K243353mediclus coOne-Fil PuttyMarch 14, 2025
K243546dentsply sironaAH Plus Endodontic SealerFebruary 13, 2025
K242934longly biotechnology (wuhan) coBioceramic Root Canal Sealer and Repair Materials (i-MTA BP)December 12, 2024
K242702spident coVioSealNovember 7, 2024
K241977longly biotechnology (wuhan) coInjectable Root Canal Bioceramic Sealer (i-MTA SP)October 3, 2024
K241457inter-medVista BC PuttyAugust 28, 2024
K240446shiva productsCalx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax July 30, 2024
K240304enpuno biotechnology coInjectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NMay 28, 2024
K240365beijing c-root dental medical devices coBioceramic Root Repair Material (C-Root BP)May 10, 2024
K232182mediclus coOne-FilJanuary 26, 2024
K232299meta biomed coCeraPuttySeptember 29, 2023
K231480genoss coBright MTA Sealer PlusJuly 28, 2023
K231387lumendoEndofillJuly 10, 2023