Fluorilaq Varnish Bubblegum 10400

GUDID 00310866001104

Fluorilaq Bubblegum with 5% Sodium Fluoride Varnish. 10 mL tube

PASCAL COMPANY, INC.

Dental cavity varnish

• Primary Device ID: 00310866001104
• NIH Device Record Key: 93f15327-00c6-4f12-a6fa-ef07c4684a49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluorilaq Varnish Bubblegum
• Version Model Number: 10400
• Catalog Number: 10400
• Company DUNS: 009260217
• Company Name: PASCAL COMPANY, 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: 8004268051
• Email: pascal@pascaldental.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00310866001104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030488

FDA Product Code

• LBH: Varnish, Cavity

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: 2019-03-04
• Device Publish Date: 2019-01-30

Devices Manufactured by PASCAL COMPANY, INC.

• 00310866002552 - KOIS KR-1 PACKER: 2024-06-12 RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 0.5MM HEAD
• 00310866002606 - KOIS KR-2 PACKER: 2024-06-12 RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 1MM HEAD
• 00310866002613 - KOIS KR-3 PACKER: 2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 1.5MM HEAD
• 00310866002620 - KOIS KR-4 PACKER: 2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 2MM HEAD
• 00310866002637 - KOIS KR-5 PACKER: 2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 2.5MM HEAD
• 00310866002644 - GET SCULPTED: 2024-05-24 Wax Carving Set
• 00310866002651 - Fluorilaq Salted Caramel (10mL) Tube: 2024-04-05 5% Sodium Fluoride with Xylitol. No separation, no mixing & no mess. Ideal for hypersensitivity treatments.
• 00310866002668 - Fluorilaq Mint (10mL) Tube: 2024-04-05 5% Fluoride Varnish with Xylitol. Ideal for cavity varnish.