PIVOT Coarse Kid's Variety Prophy Pack Box 100 1100123

GUDID D02411001233

PIVOT Coarse Kid's Variety Prophy Pack Box of 100 units each containing 1 PIVOT Non-Latex Prophy Angle Soft Cup and 1 2.0g prophy cup of NEXT Coarse Grit Prophy Paste (Bubblegum, Cherry, or Mint flavor)

Preventech

Dental polishing cup, single-use

• Primary Device ID: D02411001233
• NIH Device Record Key: d85b5714-ddd9-40c6-a636-1c04ff3f2e1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIVOT Coarse Kid's Variety Prophy Pack Box 100
• Version Model Number: 1100123
• Catalog Number: 1100123
• Company DUNS: 090735093
• Company Name: Preventech
• Device Count: 100
• 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: true
• 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	D0241100123 [Primary]
HIBCC	D02411001233 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100539

FDA Product Code

• EHK: Cup, Prophylaxis

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