ENDOCEM MTA
GUDID 08800071200079
1. Description: ENDOCEM MTA was developed for regenerative endodontic treatment such as partial pulpotomy; and is designed to prevent irritation of pulp and secondary infections. It is a powder type. Use with saline or distilled water. The mixing ratio is 300 mg / 0.12 cc. 2. Principle of operation: ENDOCEM MTA is natural pure cement based endodontic material. product based on the science of pozzolan reactions. It has a fast setting time that allows for resin bonding to occur immediately after setting. It maintains its integrity in less than ideal clinical situations, including contamination with blood or saliva and presence of inflammation or infection. 3. Storage conditions: 1) The product shall be kept out of direct sunlight and stored at room temperature. It shall not be stored in a place with high temperature and humidity. 2) The remaining material shall be disposed of. 4. Shelf life: 3 years from manufacture date if storage conditions are followed.
MARUCHI
Hygroscopic dental cement| Primary Device ID | 08800071200079 |
| NIH Device Record Key | 5e2110e2-f4e8-4445-9b04-d9ca362a3687 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENDOCEM MTA |
| Version Model Number | ENDOCEM MTA |
| Company DUNS | 557821685 |
| Company Name | MARUCHI |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800071200079 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K112078
FDA Product Code
| KIF | Resin, Root Canal Filling |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-24 |
| Device Publish Date | 2023-05-16 |
Devices Manufactured by MARUCHI
| 08800071200093 - White ENDOSEAL MTA | 2023-07-03 1. Description: White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require |
| 08800071200291 - ENDOCEM MTA PREMIXED REGULAR | 2023-07-03 ENDOCEM MTA PREMIXED REGULAR is a root canal filling material conforming to ISO 6876, in a pre-loaded syringe that does not requ |
| D075B00AHBS10003G2 - AH Plus Bioceramic Sealer | 2023-07-03 1. Description: AH Plus Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not r |
| D075BKTAHBS0000001 - AH Plus Bioceramic Sealer | 2023-07-03 1. Description: AH Plus Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not r |
| 08800071200000 - ENDOSEAL MTA | 2023-05-24 1. Description: ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. I |
| 08800071200017 - CleaniCal | 2023-05-24 1. Description: CleaniCal is a type of pre-filled syringe of Calcium Hydroxide Paste with a pH above 12.3. It is applied obturat |
| 08800071200079 - ENDOCEM MTA | 2023-05-241. Description: ENDOCEM MTA was developed for regenerative endodontic treatment such as partial pulpotomy; and is designed to prevent irritation of pulp and secondary infections. It is a powder type. Use with saline or distilled water. The mixing ratio is 300 mg / 0.12 cc. 2. Principle of operation: ENDOCEM MTA is natural pure cement based endodontic material. product based on the science of pozzolan reactions. It has a fast setting time that allows for resin bonding to occur immediately after setting. It maintains its integrity in less than ideal clinical situations, including contamination with blood or saliva and presence of inflammation or infection. 3. Storage conditions: 1) The product shall be kept out of direct sunlight and stored at room temperature. It shall not be stored in a place with high temperature and humidity. 2) The remaining material shall be disposed of. 4. Shelf life: 3 years from manufacture date if storage conditions are followed. |
| 08800071200079 - ENDOCEM MTA | 2023-05-24 1. Description: ENDOCEM MTA was developed for regenerative endodontic treatment such as partial pulpotomy; and is designed to pr |
Trademark Results [ENDOCEM MTA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOCEM MTA 79124101 4582159 Live/Registered |
MARUCHI 2012-12-07 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.