KIF · Resin, Root Canal Filling
Dental · 21 CFR 872.3820 · Class 2
Overview
| Product Code | KIF |
|---|---|
| Device Name | Resin, Root Canal Filling |
| Regulation | 21 CFR 872.3820 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | Any-Paste | Mediclus Co., Ltd. | Jan 12, 2026 | SESE |
| K252890 | ZenSeal Pro | Kerr Corporation | Jan 7, 2026 | SESE |
| K251465 | Root canal repair materials (nRoot BP) | Enpuno Biotechnology Co., Ltd. | Sep 25, 2025 | SESE |
| K252285 | Well-Root PT | Vericom Co., Ltd. | Sep 19, 2025 | SESE |
| K251884 | One-Fil Putty Injectable | Mediclus Co., Ltd. | Aug 22, 2025 | SESE |
| K251390 | MTA vpt | Voco GmbH | Jul 3, 2025 | SESE |
| K250710 | Injectable Root Canal Bioceramic Sealer (nRoot SP) | Enpuno Co., Ltd. | Jun 11, 2025 | SESE |
| K243353 | One-Fil Putty | Mediclus Co., Ltd. | Mar 14, 2025 | SESE |
| K243546 | AH Plus Endodontic Sealer | Dentsply Sirona, Inc. | Feb 13, 2025 | SESE |
| K242934 | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | Longly Biotechnology (Wuhan) Co., Ltd. | Dec 12, 2024 | SESE |
| K242702 | VioSeal | Spident Co., Ltd. | Nov 7, 2024 | SESE |
| K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. | Oct 3, 2024 | SESE |
| K241457 | Vista BC Putty | Inter-Med, Inc. | Aug 28, 2024 | SESE |
| K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | Shiva Products | Jul 30, 2024 | SESE |
| K240304 | 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 | Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., Ltd. | May 10, 2024 | SESE |
| K232182 | One-Fil | Mediclus Co., Ltd. | Jan 26, 2024 | SESE |
| K232299 | CeraPutty | Meta Biomed Co., Ltd. | Sep 29, 2023 | SESE |
| K231480 | Bright MTA Sealer Plus | Genoss Co., Ltd. | Jul 28, 2023 | SESE |
| K231387 | 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
- Angelus Industria DE Produtos Odontologicos S/A — 5 clearances
