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 Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement Hygroscopic dental cement

• 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