Diapaste
Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.
4manufacturers in China registered for this device type
10catalogue numbers in this listing
6510(k) clearances naming this product code
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 | Diadent Group Intl., Inc., Canada |
|---|---|
| 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, Exporter |
| Record published | 2016-10-04 |
| Record revised | 2018-06-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 2 to 27 °C; Special storage condition: Keep Dry and Keep away from Sunlight. |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Type C | In distribution | |
| Type C | In distribution | |
| Refill Kit | In distribution | |
| Intro Kit | In distribution | |
| Type A | In distribution | |
| Type B | In distribution | |
| Type A | In distribution | |
| Type B | In distribution | |
| Intro Kit | In distribution | |
| Refill Kit | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210333 | 2021-03-25 |
| K200174 | 2020-09-18 |
| K200175 | 2020-06-25 |
| K190091 | 2020-03-27 |
| K182009 | 2019-09-26 |
| K182625 | 2019-06-03 |
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.