1. Description: White ENDOSEAL MTA is a root canal sealer 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…
1. Description: White ENDOSEAL MTA is a root canal sealer 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. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers master cones. 2. Principle of operation: White ENDOSEAL MTA is a tricalcium-silicate based endodontic sealer as a premixed and preloaded syringe type. White ENDOSEAL MTA seals between the root canal and the root canal filling materials(ex. Gutta percha) by using sealing properties. 3. Storage conditions: 1) The product must be stored at room temperature (15 – 25°C) avoiding high temperature and humidity. 2) After use do not recap the used 24-gauge tip, remove and dispose tip as per national laws and recommendations of local authorities. 3) Clean the outside of the syringe and remove any excess sealer and twist the storage cap provided with the product tightly onto the syringe head. 4) Place the syringe into the foil pouch and ensure to seal the pouch. 4. Shelf life: 2 years from date of manufacture.
Who Else Makes It
Concentrated in Shanghai (1), Guangxi (1), Beijing (1).
Record
Regulatory record for White Endoseal MTA | 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) | K212229 |
| Record published | 2023-06-23 |
| Record revised | 2024-03-19 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 25 °C |
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.