Avalon Biomed NeoSEALER EZFlo 2.2 g Refill Syringe

GUDID 00810118106576

Avalon Biomed NeoSEALER EZFlo 2.2 g Refill Syringe

NUSMILE, LTD.

Hygroscopic dental cement

• Primary Device ID: 00810118106576
• NIH Device Record Key: b1fab139-05b4-4342-9b51-34fab14c5143
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avalon Biomed NeoSEALER EZFlo 2.2 g Refill Syringe
• Version Model Number: ANSEZRF
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118106576 [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: 2025-08-11
• Device Publish Date: 2025-08-01

Devices Manufactured by NUSMILE, LTD.

• 00810118106576 - Avalon Biomed NeoSEALER EZFlo 2.2 g Refill Syringe: 2025-08-11Avalon Biomed NeoSEALER EZFlo 2.2 g Refill Syringe
• 00810118106576 - Avalon Biomed NeoSEALER EZFlo 2.2 g Refill Syringe: 2025-08-11 Avalon Biomed NeoSEALER EZFlo 2.2 g Refill Syringe
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• 00810118106460 - NuSmile NuNamel Pit & Fissure Sealant: 2025-08-01 NuNamel Pit & Fissure Sealant 1 x 1.2 ml syringe + 15 tips Starter Kit
• 00810118106477 - NuSmile NuNamel Pit & Fissure Sealant: 2025-08-01 NuNamel Pit & Fissure Sealant 4 x 1.2 ml syringe + 20 tips Professional Kit
• 00810118106484 - NuSmile NuNamel Pit & Fissure Sealant: 2025-08-01 NuNamel Pit & Fissure Sealant 10 x 1.2 ml syringes (no tips) Value Kit
• 00810118106491 - Dentsply ProRoot BioSealer 2.2 g Kit, 20 Basic Flex Tips: 2025-07-23 Dentsply ProRoot BioSealer 2.2 g Kit, 20 Basic Flex Tips