DIA-ROOT BIO MTA 1003-601

GUDID 08806383565783

DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include : repair of root resorption, root end filling, apexification, and pediatric pulpotomy.

DiaDent Group International

Endodontic filling/sealing material

• Primary Device ID: 08806383565783
• NIH Device Record Key: 8287795d-340b-469b-8dad-3953decd5808
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIA-ROOT BIO MTA
• Version Model Number: DIA-ROOT BIO MTA 0.5g
• Catalog Number: 1003-601
• Company DUNS: 687789453
• Company Name: DiaDent Group International
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry and Keep away from Sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806383565783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200174

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: 2021-02-04
• Device Publish Date: 2021-01-27

Devices Manufactured by DiaDent Group International

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• 08806383565608 - DISPOSABLE TIPS: 2023-07-05 Disposable Tip for DiaFil Flow
• 08806383565615 - DISPOSABLE TIPS: 2023-07-05 Disposable Tips for DiaEtch
• 08806383565660 - DISPOSABLE TIPS: 2023-07-05 Disposable Tips for DiaFil Flow
• 08806383565677 - DISPOSABLE TIPS: 2023-07-05 Disposable Tips for DiaEtch
• 08806383576475 - GUTTA PERCHA POINTS: 2023-07-05 Gutta Percha Points is used to root canal filing material.
• 08806383576482 - GUTTA PERCHA POINTS: 2023-07-05 Gutta Percha Points is used to root canal filing material.