Kolorz Prophylaxis Paste

GUDID D0337884110

Kolorz Prophylaxis Paste Blueberry Medium Grit (200 Unit Dose Cups)

DMG AMERICA, LLC

Dentifrice

• Primary Device ID: D0337884110
• NIH Device Record Key: 54e7ad90-af1c-4e57-96dd-8f27f295aa04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kolorz Prophylaxis Paste
• Version Model Number: 788411
• Company DUNS: 106792427
• Company Name: DMG AMERICA, LLC
• Device Count: 200
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0337884110 [Unit of Use]
HIBCC	D0337884111 [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: 2025-06-12
• Device Publish Date: 2025-06-04

On-Brand Devices [Kolorz Prophylaxis Paste]

• D0337884110: Kolorz Prophylaxis Paste Blueberry Medium Grit (200 Unit Dose Cups)
• D0337884100: Kolorz Prophylaxis Paste Blueberry Fine Grit (200 Unit Dose Cups)