CeraPutty CP10
CeraPutty is a premixed bioceramic material for permanent root canal repair and filling. Its uses include root perforation and resorption repair, root-end filling, apexification and pulp…
CeraPutty is a premixed bioceramic material for permanent root canal repair and filling. Its uses include root perforation and resorption repair, root-end filling, apexification and pulp capping. It is supplied in a preloaded syringe for placement by a dentist.
The white putty contains calcium silicate compounds, zirconium dioxide and a thickening agent. Moisture in the oral cavity causes it to set and harden. Zirconium dioxide makes the material radiopaque, allowing it to be seen on dental radiographs.
Preparation
The material is ready to use without additional mixing. It is supplied nonsterile and requires moisture to set, so its handling follows the requirements of a hydraulic root repair material.
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 | Meta Biomed Co., Ltd., South Korea |
|---|---|
| FDA product code | KIF |
| Device type | Resin, Root Canal Filling |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3820 |
| Establishment | Repacker / relabeller, Private-label distributor, Manufacturer |
| 510(k) | K232299 |
| Record published | 2023-11-15 |
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 |
|---|---|---|
| 6010 | 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 |
|---|---|
| K232299 | 2023-09-29 |
| K230010 | 2023-04-13 |
| K210904 | 2021-06-30 |
| K202617 | 2021-04-14 |
| K190503 | 2019-06-07 |
| K190510 | 2019-05-29 |
| K042769 | 2004-11-24 |
| K032605 | 2003-10-08 |
| K032603 | 2003-10-07 |
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.