Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3820](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3820) → KIF — Resin, Root Canal Filling # KIF · Resin, Root Canal Filling _Dental · 21 CFR 872.3820 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF ## Overview - **Product Code:** KIF - **Device Name:** Resin, Root Canal Filling - **Regulation:** [21 CFR 872.3820](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3820) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **3rd-party reviewable:** yes ## Identification A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth. ## Classification Rationale (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device. ## Recent Cleared Devices (20 of 143) Showing 20 most recent of 143 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253167](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K253167.md) | Any-Paste | Mediclus Co., Ltd. | Jan 12, 2026 | SESE | | [K252890](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K252890.md) | ZenSeal Pro | Kerr Corporation | Jan 7, 2026 | SESE | | [K251465](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K251465.md) | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd. | Sep 25, 2025 | SESE | | [K252285](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K252285.md) | Well-Root PT | Vericom Co., Ltd. | Sep 19, 2025 | SESE | | [K251884](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K251884.md) | One-Fil Putty Injectable | Mediclus Co., Ltd. | Aug 22, 2025 | SESE | | [K251390](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K251390.md) | MTA vpt | Voco GmbH | Jul 3, 2025 | SESE | | [K250710](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K250710.md) | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | Jun 11, 2025 | SESE | | [K243353](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K243353.md) | One-Fil Putty | Mediclus Co., Ltd. | Mar 14, 2025 | SESE | | [K243546](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K243546.md) | AH Plus Endodontic Sealer | Dentsply Sirona, Inc. | Feb 13, 2025 | SESE | | [K242934](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K242934.md) | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | Longly Biotechnology (Wuhan) Co., Ltd. | Dec 12, 2024 | SESE | | [K242702](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K242702.md) | VioSeal | Spident Co., Ltd. | Nov 7, 2024 | SESE | | [K241977](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K241977.md) | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. | Oct 3, 2024 | SESE | | [K241457](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K241457.md) | Vista BC Putty | Inter-Med, Inc. | Aug 28, 2024 | SESE | | [K240446](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K240446.md) | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | Shiva Products | Jul 30, 2024 | SESE | | [K240304](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K240304.md) | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) | Enpuno Biotechnology Co., Ltd. | May 28, 2024 | SESE | | [K240365](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K240365.md) | Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., Ltd. | May 10, 2024 | SESE | | [K232182](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K232182.md) | One-Fil | Mediclus Co., Ltd. | Jan 26, 2024 | SESE | | [K232299](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K232299.md) | CeraPutty | Meta Biomed Co., Ltd. | Sep 29, 2023 | SESE | | [K231480](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K231480.md) | Bright MTA Sealer Plus | Genoss Co., Ltd. | Jul 28, 2023 | SESE | | [K231387](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF/K231387.md) | Endofill | Lumendo AG | Jul 10, 2023 | SESE | ## Top Applicants - Meta Biomed Co., Ltd. — 9 clearances - Innovative Bioceramix, Inc. — 8 clearances - Maruchi — 7 clearances - DiaDent Group International — 6 clearances - Ultradent Products, Inc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KIF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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