One-Fil Putty
One-Fil Putty is a premixed endodontic repair material that hardens in the presence of moisture. The white paste is intended for permanent root-canal repair applications and is supplied in…
One-Fil Putty is a premixed endodontic repair material that hardens in the presence of moisture. The white paste is intended for permanent root-canal repair applications and is supplied in glass syringes.
Its formulation contains tricalcium aluminate compounds, zirconium oxide and hydrophilic polymer thickening agents. The paste is delivered ready to use rather than mixed from separate components.
Listed Item
One-Fil Putty is an endodontic sealing material designed to provide a biocompatible and effective seal for root canal filling.
Repair Applications
Indications include furcation or root perforation repair, internal or external resorption treatment, retrofilling during endodontic surgery, direct or indirect pulp capping, apexification, apexogenesis and pulpotomy. The material is supplied nonsterile.
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) | K243353 |
| 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 | Handling environment temperature 15 to 25 °C |
| Sizes | Weight 0.25 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 509-2 One-Fil Putty | Weight 0.25 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.