Endocem MTA Premixed Regular
Endocem MTA Premixed Regular is a calcium-silicate-based endodontic filling and repair paste supplied in a preloaded syringe. It sets by taking up moisture from the root-canal environment.…
Endocem MTA Premixed Regular is a calcium-silicate-based endodontic filling and repair paste supplied in a preloaded syringe. It sets by taking up moisture from the root-canal environment.
The premixed formulation contains calcium silicate, calcium aluminate, zirconium dioxide and other ingredients including bentonite and hydroxypropyl methylcellulose. No separate powder-and-liquid mixing is required before delivery.
Listed Item
ENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. It is designed to prevent irritation of pulp and secondary infections. ENDOCEM MTA PREMIXED REGULAR is a tricalcium-silicate based endodontic material as a premixed and preloaded syringe type. It conducts hydration reaction by absorbing the moisture around the root canal. The main compositions, directly relating to hydration reaction forming the hydrate gel, are calcium silicate and calcium aluminate. Bentonite Clay is added for hydrophilic properties inside the root canal so that it helps effective hydration reaction in the environment where there is a small amount of moisture. Other composition is relating to making ENDOCEM MTA PREMIXED REGULAR a premixed syringe type product for convenience usage.
Repair Uses
The material is used for direct or indirect pulp capping, root-end filling and repair of perforations. Moisture initiates its setting reaction after placement. The product is supplied nonsterile as a ready-to-use paste, with delivery from the syringe suited to the selected dental repair site.
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 | Maruchi, South Korea |
|---|---|
| FDA product code | KIF |
| Device type | Resin, Root Canal Filling |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3820 |
| Establishment | Manufacturer |
| 510(k) | K213757 |
| Record published | 2023-06-23 |
| Record revised | 2024-03-19 (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, serial number |
| Storage | Storage environment temperature 15 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ENDOCEM MTA PREMIXED REGULAR | 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 |
|---|---|
| K213757 | 2023-02-14 |
| K212229 | 2021-08-13 |
| K202015 | 2021-03-24 |
| K170175 | 2018-02-26 |
| K133042 | 2014-05-12 |
| K133054 | 2014-05-12 |
| K112078 | 2012-03-19 |
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.