SmartMTA Capsule
SmartMTA Capsule is a dental root repair material supplied as separate powder and water within a capsule. Mixing produces a putty that gradually hardens in the oral environment for root…
SmartMTA Capsule is a dental root repair material supplied as separate powder and water within a capsule. Mixing produces a putty that gradually hardens in the oral environment for root canal filling, perforation repair, apical plugs, root-end filling and selected pulp procedures.
The capsule separates cement powder and distilled water in two chambers. Pressing the bottom punctures a foil barrier so the contents can mix immediately before use. Each capsule contains 0.2 g of powder and 0.14 ml of water.
Listed Item
SmartMTA Capsule – 20 pack
Composition and Packs
The powder contains calcium carbonate, silicon dioxide, aluminum oxide and zirconium oxide. The product is supplied in ten- or twenty-capsule packs for adult and pediatric dental use.
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 | Sprig Oral Health Technologies, Inc., United States |
|---|---|
| FDA product code | KIF |
| Device type | Resin, Root Canal Filling |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3820 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K230797 |
| Record published | 2023-05-18 |
| Record revised | 2025-04-04 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R-MTA-C20 | In distribution | |
| R-MTA-C10 | 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 |
|---|---|
| K230797 | 2023-03-24 |
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.