ENDOCEM MTA PREMIXED REGULAR

GUDID 08800071200291

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.

MARUCHI

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• Primary Device ID: 08800071200291
• NIH Device Record Key: e86e8d37-5d4e-4e0b-b8df-4c573d27e927
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOCEM MTA PREMIXED REGULAR
• Version Model Number: ENDOCEM MTA PREMIXED REGULAR
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• 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
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800071200291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213757

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: 2023-07-03
• Device Publish Date: 2023-06-23

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: 2023-07-03ENDOCEM 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.
• 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: 2023-05-24 1. Description: ENDOCEM MTA was developed for regenerative endodontic treatment such as partial pulpotomy; and is designed to pr