ENDOSEAL MTA

GUDID 08800071200000

1. Description: ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal, including accessory and lateral canals. It is eugenol-free and will not impede adhesion inside the root canal. 2. Principle of operation: The essential principle of operation is that calcium silicate, an ingredient of natural cement in the Endoseal MTA, quickly conducts hydration reactions by absorbing moisture around the mouth and root canals due to hygroscopic materials, and starts to harden. 3. Storage conditions: 1) The product should be stored at room temperature avoiding high temperature and humidity. 2) The product use immediately after replacing the 24 gauge tip because it will be hardened when in contact with air. 3) After using the 24 gauge tip, keep the metal part cut off. A new 24 gauge tip replaces it in next use. 4. Shelf life: 2 years from date of manufacture.

MARUCHI

Hygroscopic dental cement

• Primary Device ID: 08800071200000
• NIH Device Record Key: 6620f431-83d9-4986-9a04-5ed2fd182d0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSEAL MTA
• Version Model Number: ENDOSEAL 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	08800071200000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170175

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: 2023-05-241. Description: ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal, including accessory and lateral canals. It is eugenol-free and will not impede adhesion inside the root canal. 2. Principle of operation: The essential principle of operation is that calcium silicate, an ingredient of natural cement in the Endoseal MTA, quickly conducts hydration reactions by absorbing moisture around the mouth and root canals due to hygroscopic materials, and starts to harden. 3. Storage conditions: 1) The product should be stored at room temperature avoiding high temperature and humidity. 2) The product use immediately after replacing the 24 gauge tip because it will be hardened when in contact with air. 3) After using the 24 gauge tip, keep the metal part cut off. A new 24 gauge tip replaces it in next use. 4. Shelf life: 2 years from date of manufacture.
• 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: 2023-05-24 1. Description: ENDOCEM MTA was developed for regenerative endodontic treatment such as partial pulpotomy; and is designed to pr