Brasseler USA
BC RRM FAST SET PUTTY 1P .3G EndoSequence
4manufacturers in China registered for this device type
19catalogue numbers in this listing
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 | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | KIF |
| Device type | Resin, Root Canal Filling |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3820 |
| 510(k) | K082943 |
| Record published | 2022-12-01 |
| Record revised | 2024-10-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5027126EU | In distribution | |
| 5026825U0 | In distribution | |
| 5017560EU | In distribution | |
| 5028586G0 | In distribution | |
| 5029291U0 | In distribution | |
| 5024355U0 | In distribution | |
| 5030783U0 | In distribution | |
| 5018265U0 | In distribution | |
| 5026817G0 | In distribution | |
| 5031640U0 | In distribution | |
| 5018266U0 | In distribution | |
| 5026816G0 | In distribution | |
| 5031639U0 | In distribution | |
| 5026825EU | In distribution | |
| 5024200U0 | In distribution | |
| 5028170U0 | In distribution | |
| 5017560U0 | In distribution | |
| 5031795U0 | In distribution | |
| 5018264U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Calplus | Prevest Denpro Limited | 5 |
Showing 12 of 204. All products under Resin, Root Canal Filling
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.