NeoMTA2 Bioceramic Reparative Cement 2.5 g Kit

GUDID 00810118101168

NeoMTA2 Bioceramic Reparative Cement 2.5 g Kit

NUSMILE, LTD.

Hygroscopic dental cement

• Primary Device ID: 00810118101168
• NIH Device Record Key: d30649d2-83ac-4a05-b13b-f481aba10324
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoMTA2 Bioceramic Reparative Cement 2.5 g Kit
• Version Model Number: ZNM25
• Company DUNS: 185497372
• Company Name: NUSMILE, LTD.
• Device Count: 1
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118101168 [Primary]

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: 2023-03-29
• Device Publish Date: 2023-03-21

Devices Manufactured by NUSMILE, LTD.

• 00810118103650 - Zarc by Avalon Biomed Gutta Perch Obturator (Pellets): 2026-01-23 100 units
• 00810118105555 - Ultradent MTApex 5.0 g Powder: 2026-01-22 Ultradent MTApex 5.0 g Powder
• 00810118105562 - Ultradent MTApex 5.0 ml Gel: 2026-01-22 Ultradent MTApex 5.0 ml Gel
• 00810118106620 - EdgeEndo Biocermaic Sealer Tip: 2026-01-22 EdgeEndo Biocermaic Sealer Tip 15 Pack
• 00810118106637 - Dentsply ProRoot Flex Tip: 2026-01-22 Dentsply ProRoot Flex Tip 20 Pack
• 00810118106644 - NuSmile ReVIVE Crowns: 2025-12-04 NuSmile ReVIVE Anterior Pediatric Crowns Starter Kit - 48 Crowns, Light Shade
• 00810118106651 - NuSmile ReVIVE Crowns: 2025-12-04 NuSmile ReVIVE Anterior Pediatric Crowns Professional Kit - 88 Crowns, Light Shade
• 00810118106682 - NuSmile ReVIVE Crowns: 2025-12-04 NuSmile ReVIVE Regular First and Second Primary Molar - Professional Kit - 80 Crowns, Light Shade