MAARC DENTAL -Rootfyx 9107/0.5x4

GUDID 08906110443039

Rootfyx (Bioceramic sealer) is used for root canal filling after the removal of infected pulp tissue in the root canal. Rootfyx is in the form of a flowable paste and can be immediately inserted into the root canal using a disposable tip. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.

SHIVA PRODUCTS

Hygroscopic dental cement

• Primary Device ID: 08906110443039
• NIH Device Record Key: 276dc6ac-a8f1-4e15-801d-025b9d833e5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAARC DENTAL -Rootfyx
• Version Model Number: 9107/0.5x4
• Catalog Number: 9107/0.5x4
• Company DUNS: 737988276
• Company Name: SHIVA PRODUCTS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 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 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08906110443039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240446

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: 2024-10-10
• Device Publish Date: 2024-10-02

Devices Manufactured by SHIVA PRODUCTS

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• 08906110440175 - Maarc dental - Articulating Paper: 2024-10-10 A diagnostic tool used in dentistry to highlight occlusal contacts and the distribution of occlusal forces. That is, it marks th
• 08906110440397 - MAARC DENTAL-Calcium Hydroxide Powder: 2024-10-10 Calcium hydroxide is used as an agent to induce apexification in pediatric endodontics. The product may also be used as a pulp c
• 08906110440403 - MAARC DENTAL-Calx-O: 2024-10-10 It is a water based white paste consisting of premixed Calcium Hydroxide and Barium Sulphate. Supplied in a multi dose syringe w
• 08906110440458 - MAARC DENTAL - Ceraseal-B: 2024-10-10 MAARC CeraSeal-B is MTA based Bio-ceramic Root Canal Sealer.
• 08906110443039 - MAARC DENTAL -Rootfyx: 2024-10-10Rootfyx (Bioceramic sealer) is used for root canal filling after the removal of infected pulp tissue in the root canal. Rootfyx is in the form of a flowable paste and can be immediately inserted into the root canal using a disposable tip. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
• 08906110443039 - MAARC DENTAL -Rootfyx: 2024-10-10 Rootfyx (Bioceramic sealer) is used for root canal filling after the removal of infected pulp tissue in the root canal. Rootfyx
• 08906110443053 - MAARC DENTAL - Sealmax +: 2024-10-10 Sealmax+ is a MTA based Bioceramic root canal sealing material supplied in the form of powder and resin. The powder and resin a