One-Fil
One-Fil is a premixed calcium silicate paste for permanent sealing of root canals. It is supplied ready to use in a plastic syringe and requires water to set and harden. Moisture from…
One-Fil is a premixed calcium silicate paste for permanent sealing of root canals. It is supplied ready to use in a plastic syringe and requires water to set and harden.
Moisture from dentin tubules drives a hydration reaction in the material. The resulting sealer is insoluble and radiopaque, allowing its presence to be distinguished on radiographic images.
Listed Item
One-Fil is a permanent sealing of root canal.
Delivery System
The syringe system includes a plunger, holder and disposable dispensing tips for applying the injectable single paste. One-Fil is supplied nonsterile for prescription use in a clinical setting.
Who Else Makes It
Concentrated in Shanghai (1), Guangxi (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
| Beijing C-Root Dental Medical Devices Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Enpuno Biotechnology Co., Ltd. | Changsha | Hunan | Manufacturer | 1 |
Record
| Listed by | Mediclus Co., Ltd., South Korea |
|---|---|
| FDA product code | KIF |
| Device type | Resin, Root Canal Filling |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3820 |
| Establishment | Manufacturer |
| 510(k) | K232182 |
| Record published | 2026-05-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store at a temperature between 15°C and 25°C. This product is sensitive to humidity, so keep the syringe cap tightly clo |
| Sizes | Weight 2 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 508-1 One-Fil | Weight 2 g | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Brasseler USA | Peter Brasseler Holdings, LLC | 19 |
| Root canal repair materials | Enpunuo Biotechnology Co., Ltd. | 12 |
| Diapaste | Diadent Group Intl., Inc. | 10 |
| NeoMTA Plus | Avalon Biomed, Inc. | 10 |
| C-Root | Beijing C-Root Dental Medical Devices Co., Ltd. | 10 |
| MetaSEAL™ | Parkell, Inc. | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Grey MTA Plus | Avalon Biomed, Inc. | 7 |
| EndoREZ | Ultradent Products Inc. | 6 |
| Cerafill RCS | Prevest Denpro Limited | 6 |
| MTA Angelus | Angelus Industria DE Produtos Odontologicos S/A | 5 |
| Injectable Root Canal Bioceramic Sealer(nRoot SP) | Enpunuo Biotechnology Co., Ltd. | 5 |
Showing 12 of 204. All products under Resin, Root Canal Filling
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253167 | 2026-01-12 |
| K251884 | 2025-08-22 |
| K243353 | 2025-03-14 |
| K232182 | 2024-01-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.