NuSmile NeoMTA 2 none

GUDID 00850008515002

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.

NUSMILE, LTD.

Endodontic filling/sealing material

• Primary Device ID: 00850008515002
• NIH Device Record Key: 062c38f1-87ec-4206-9dc2-accbead2c12a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuSmile NeoMTA 2
• Version Model Number: NMTA20.5
• Catalog Number: none
• Company DUNS: 185497372
• Company Name: NUSMILE, LTD.
• 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

Customer Support Contacts

• Phone: +1 713.861.0033
• Email: info@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com
• Phone: 832-540-5964
• Email: plara@nusmile.com

Device Dimensions

• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram
• Weight: 0.5 Gram

Operating and Storage Conditions

• 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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 bottles 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	00850008515002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161239

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: 2019-09-19
• Device Publish Date: 2019-09-11

On-Brand Devices [NuSmile NeoMTA 2]

• 00850008515026: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cem
• 00850008515019: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cem
• 00850008515002: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cem