Dentsply ProRoot BioSealer 2.2 g Kit, 20 Basic Flex Tips

GUDID 00810118106491

Dentsply ProRoot BioSealer 2.2 g Kit, 20 Basic Flex Tips

NUSMILE, LTD.

Hygroscopic dental cement

• Primary Device ID: 00810118106491
• NIH Device Record Key: 0fefdb89-113a-4d5a-9510-5db2b145dcda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentsply ProRoot BioSealer 2.2 g Kit, 20 Basic Flex Tips
• Version Model Number: 60620140
• 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

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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810118106491 [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: 2025-07-23
• Device Publish Date: 2025-07-15

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