MTAFlow Powder 2.0 gm (Version 2)

GUDID 00850008515187

Indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing root canals.

NUSMILE, LTD.

Endodontic filling/sealing material

• Primary Device ID: 00850008515187
• NIH Device Record Key: 4248f82d-34d4-4ffe-95f9-11310da5bbc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTAFlow Powder 2.0 gm (Version 2)
• Version Model Number: 14084
• 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: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com
• Phone: 8325405964
• Email: plara@nusmile.com

Device Dimensions

• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Moisture will reduce the shelf life pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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 pf the powder
• Special Storage Condition, Specify: Between 0 and 0 *Keep the 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	00850008515187 [Primary]

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: 2020-07-28
• Device Publish Date: 2020-07-20

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