NeoMTA Plus

GUDID 08575700061252

Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.

Avalon Biomed Inc.

Endodontic filling/sealing material

• Primary Device ID: 08575700061252
• NIH Device Record Key: eed9b6f2-2c00-4107-88dc-e7131bbb1998
• Commercial Distribution Discontinuation: 2017-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NeoMTA Plus
• Version Model Number: MN250
• Company DUNS: 969855647
• Company Name: Avalon Biomed Inc.
• 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: 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

Device Dimensions

• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram
• Weight: 2.5 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Moisture will reduce the shelf life of the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep bottle tightly closed
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Moisture will reduce the shelf life of the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep bottle tightly closed
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Moisture will reduce the shelf life of the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep bottle tightly closed
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Moisture will reduce the shelf life of the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep bottle tightly closed
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Moisture will reduce the shelf life of the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep bottle tightly closed
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Moisture will reduce the shelf life of the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep bottle tightly closed
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Moisture will reduce the shelf life of the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep bottle tightly closed
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Moisture will reduce the shelf life of the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep bottle tightly closed
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Moisture will reduce the shelf life of the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep bottle tightly closed
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	08575700061252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140955

FDA Product Code

• KIF: Resin, Root Canal Filling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-08-19
• Device Publish Date: 2017-12-19

On-Brand Devices [NeoMTA Plus]

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• 00857570006150: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
• 00857570006143: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
• 00857570006112: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
• 00857570006105: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
• 00857570006099: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
• 00857570006082: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
• 00857570006075: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
• 00857570006068: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce
• 08575700061252: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce