C-Root
C-Root SP is a root canal sealer for permanent obturation after pulp extirpation or after infected or necrotic pulp is removed and intracanal dressings are placed. It is suitable for…
C-Root SP is a root canal sealer for permanent obturation after pulp extirpation or after infected or necrotic pulp is removed and intracanal dressings are placed. It is suitable for single-cone and lateral-condensation techniques.
The radiopaque, aluminum-free material is based on strontium silicates and requires water to set and harden. It is supplied in a preloaded syringe with disposable intracanal tips.
Delivery Form
The sealer is a premixed, ready-to-use injectable paste. It can be delivered through disposable intracanal tips or by traditional placement methods.
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 | Beijing C-Root Dental Medical Devices Co., Ltd., China |
|---|---|
| FDA product code | KIF |
| Device type | Resin, Root Canal Filling |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3820 |
| Establishment | Manufacturer |
| 510(k) | K212983 |
| Record published | 2023-11-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 60 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0.5g | In distribution | |
| 2g | In distribution | |
| 1g | In distribution | |
| 0.2g | In distribution | |
| 0.5g | In distribution | |
| 1g | In distribution | |
| 2g | In distribution | |
| 1g | In distribution | |
| 0.5g | In distribution | |
| 1g | 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 |
| 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 |
| Calplus | Prevest Denpro Limited | 5 |
Showing 12 of 204. All products under Resin, Root Canal Filling
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240365 | 2024-05-10 |
| K212983 | 2021-12-08 |
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.