Radent Prophy Paste, Medium, Grit Mint Jar 13600

GUDID 00310866001319

Prophy Paste with fluoride ion content of 1.23%; Medium grit, mint flavor, 12 oz jar

PASCAL COMPANY, INC.

Dentifrice

• Primary Device ID: 00310866001319
• NIH Device Record Key: 954ceafb-1c50-4c7b-a0cd-7d517a27abfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radent Prophy Paste, Medium, Grit Mint Jar
• Version Model Number: 13600
• Catalog Number: 13600
• 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: 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: 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	00310866001319 [Primary]

FDA Product Code

• EJR: Agent, Polishing, Abrasive, Oral 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: 2019-03-01
• Device Publish Date: 2019-01-29

Devices Manufactured by PASCAL COMPANY, INC.

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• 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
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• 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.