NEXT Coarse Kid's Variety Prophy Paste Box 200 221123

GUDID D0242211233

NEXT Coarse Kid's Variety Prophy Paste Box of 200 2.0g prophy cup units (Cherry, Bubblegum, or Mint flavor) for dental prophylaxis procedures

Preventech

Dentifrice

• Primary Device ID: D0242211233
• NIH Device Record Key: d27be2cf-4d7f-4fef-94a4-1cdaba3f1497
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXT Coarse Kid's Variety Prophy Paste Box 200
• Version Model Number: 221123
• Catalog Number: 221123
• Company DUNS: 090735093
• Company Name: Preventech
• Device Count: 200
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com
• Phone: 7048492416
• Email: customerservice@preventech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D024221123 [Primary]
HIBCC	D0242211233 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100539

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: 2023-06-21
• Device Publish Date: 2023-06-13