Cerafill RCS
Cerafill RCS is an endodontic sealer used for permanent sealing of root canals. It is based on mineral trioxide aggregate, or MTA, and can be used with or without other root canal…
Cerafill RCS is an endodontic sealer used for permanent sealing of root canals. It is based on mineral trioxide aggregate, or MTA, and can be used with or without other root canal obturation materials. It is supplied premixed in a preloaded syringe.
The syringe dispenses the sealer into the root canal. The material is intended to fill the canal space, including accessory and lateral canals. It is eugenol-free, distinguishing its formulation from eugenol-containing sealers.
Material Timing
The material has a working time of twenty-five to thirty minutes and a setting time of twenty-four hours. Its role is permanent canal sealing during endodontic treatment.
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 | Prevest Denpro Limited, India |
|---|---|
| FDA product code | KIF |
| Device type | Resin, Root Canal Filling |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3820 |
| Establishment | Manufacturer |
| 510(k) | K212563 |
| Record published | 2023-01-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Regular Pack in Box | In distribution | |
| Regular Pack in Plastic Pouch | In distribution | |
| Regular Pack in Box | In distribution | |
| Trial Pack | In distribution | |
| Trial Pack | In distribution | |
| Regular Pack in Plastic Bag | 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 |
| MTA Angelus | Angelus Industria DE Produtos Odontologicos S/A | 5 |
| Injectable Root Canal Bioceramic Sealer(nRoot SP) | Enpunuo Biotechnology Co., Ltd. | 5 |
| Calplus | Prevest Denpro Limited | 5 |
Showing 12 of 204. All products under Resin, Root Canal Filling
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212563 | 2022-05-23 |
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.