Choice 2 Try-In Paste C-412B1

GUDID 00810111540698

Choice 2 Try-In Paste B1 2g Syringe

BISCO INC.

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• Primary Device ID: 00810111540698
• NIH Device Record Key: 9f1ec29c-bd78-4c52-b01c-a8bf3d10e8ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Choice 2 Try-In Paste
• Version Model Number: C-412B1
• Catalog Number: C-412B1
• Company DUNS: 053529939
• Company Name: BISCO INC.
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111540698 [Primary]
HIBCC	D757C412B10 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993192

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

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: 2022-10-19
• Device Publish Date: 2022-10-11

On-Brand Devices [Choice 2 Try-In Paste]

• D757C412TRP1: Choice 2 Try-In Paste Translucent 2g Syringe Pkg
• D757C412TR0: Choice 2 Try-In Paste Translucent 2g Syringe
• D757C412OPP1: Choice 2 Try-In Paste Opaque 2g Syringe Pkg
• D757C412OP0: Choice 2 Try-In Paste Opaque 2g Syringe
• D757C412MOP1: Choice 2 Try-In Paste Milky Opaque 2g Syringe Pkg
• D757C412MO0: Choice 2 Try-In Paste Milky Opaque 2g Syringe
• D757C412MBP1: Choice 2 Try-In Paste Milky Bright 2g Syringe Pkg
• D757C412MB0: Choice 2 Try-In Paste Milky Bright 2g Syringe
• D757C412B1P1: Choice 2 Try-In Paste B1 2g Syringe Pkg
• D757C412B10: Choice 2 Try-In Paste B1 2g Syringe
• D757C412A3P1: Choice 2 Try-In Paste A3 2g Syringe Pkg
• D757C412A30: Choice 2 Try-In Paste A3 2g Syringe
• D757C412A2P1: Choice 2 Try-In Paste A2 2g Syringe Pkg
• D757C412A20: Choice 2 Try-In Paste A2 2g Syringe
• D757C412A1P1: Choice 2 Try-In Paste A1 2g Syringe Pkg
• D757C412A10: Choice 2 Try-In Paste A1 2g Syringe
• 00810111540780: Choice 2 Try-In Paste Translucent 2g Syringe Pkg
• 00810111540773: Choice 2 Try-In Paste Translucent 2g Syringe
• 00810111540766: Choice 2 Try-In Paste Opaque 2g Syringe Pkg
• 00810111540759: Choice 2 Try-In Paste Opaque 2g Syringe
• 00810111540742: Choice 2 Try-In Paste Milky Opaque 2g Syringe Pkg
• 00810111540735: Choice 2 Try-In Paste Milky Opaque 2g Syringe
• 00810111540728: Choice 2 Try-In Paste Milky Bright 2g Syringe Pkg
• 00810111540711: Choice 2 Try-In Paste Milky Bright 2g Syringe
• 00810111540667: Choice 2 Try-In Paste A2 2g Syringe Pkg
• 00810111540650: Choice 2 Try-In Paste A2 2g Syringe
• 00810111540643: Choice 2 Try-In Paste A1 2g Syringe Pkg
• 00810111540636: Choice 2 Try-In Paste A1 2g Syringe
• 00810111540674: Choice 2 Try-In Paste A3 2g Syringe
• 00810111540704: Choice 2 Try-In Paste B1 2g Syringe Pkg
• 00810111540698: Choice 2 Try-In Paste B1 2g Syringe
• 00810111540681: Choice 2 Try-In Paste A3 2g Syringe Pkg