FluoroCal B-3001

GUDID D757B30010

FluoroCal Unit Dose (.4ml)

BISCO INC.

Dental coating, tooth-desensitizing, professional

• Primary Device ID: D757B30010
• NIH Device Record Key: 9aa7f361-6b87-41ec-ad1a-4e2639292120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FluoroCal
• Version Model Number: B-3001
• Catalog Number: B-3001
• 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: 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D757B30010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182917

FDA Product Code

• LBH: Varnish, Cavity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-09-09
• Device Publish Date: 2017-06-12

On-Brand Devices [FluoroCal]

• D757B30010: FluoroCal Unit Dose (.4ml)
• D757B30501K1: FluoroCal 50ct Unit Dose Pkg
• 00810111542548: FluoroCal 50ct Unit Dose Pkg Spearmint
• 00810111542890: FluoroCal 50ct Unit Dose Pkg Green Apple
• 00810111542876: FluoroCal 50ct Unit Dose Pkg Bubble Gum
• 00810111542913: FluoroCal - 48ct Unit Dose Pkg Assorted: 16 UDs of each flavor (Bubble Gum, Green Apple, & Spea
• 00810111542906: FluoroCal - 3 Unit Dose Sample Pkg Assorted: 1 UDs of each flavor (Bubble Gum, Green Apple, & S