NuSmile NeoMTA

GUDID 00862487000351

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.

Glass ionomer dental cement

• Primary Device ID: 00862487000351
• NIH Device Record Key: 000951fc-ba14-45f1-8451-3ddd96f134d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuSmile NeoMTA
• Version Model Number: NMTA 1.0
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 713.861.0033
• Email: info@nusmilecrowns.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
• 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: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 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 *Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature
• 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
• 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	00862487000351 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-11

On-Brand Devices [NuSmile NeoMTA]

• 00862487000351: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cem
• 00862487000320: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cem
• 00862487000313: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cem
• 00862487000306: Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cem