NeoSEALER EZ-Flo (1.5 g syringe & 15 Tips) Starter Kit

GUDID 00810118103735

For use in obturating root canals as part of orthograde root canal therapy with gutta percha.

NUSMILE, LTD.

Hygroscopic dental cement

• Primary Device ID: 00810118103735
• NIH Device Record Key: 8331d3d0-721b-4f6b-9703-3443737e8cbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoSEALER EZ-Flo (1.5 g syringe & 15 Tips) Starter Kit
• Version Model Number: ANSEZFS
• 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: true
• Device Combination Product: false
• Single Use: false
• 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

Device Dimensions

• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram
• Weight: 2.2 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit
• Storage Environment Temperature: Between 72 Degrees Fahrenheit and 0 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118103735 [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: 2023-11-07
• Device Publish Date: 2023-10-30

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