CeraPutty CP05
CeraPutty CP05 is a premixed bioceramic material used by dentists for permanent root repair. Its applications include repairing root perforations and resorption, filling root ends,…
CeraPutty CP05 is a premixed bioceramic material used by dentists for permanent root repair. Its applications include repairing root perforations and resorption, filling root ends, apexification and pulp capping. It is supplied ready for placement from a preloaded syringe.
The calcium silicate material sets and hardens in the presence of moisture in the mouth, without requiring additional mixing. Zirconium dioxide provides radiopacity, allowing the material to be seen on dental X-ray images. The formulation also contains a thickening agent.
Composition and Supply
The inorganic formulation includes tricalcium silicate, dicalcium silicate, tricalcium aluminate and zirconium dioxide. The material is white, is supplied nonsterile and has a two-year shelf life.
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 |
|---|---|---|
| 6011 | 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.