PIVOT Plus Spiral Non-Latex Contra Disposable Prophy Angle Soft Cup Box 144 1144443

GUDID D02411444433

PIVOT Plus Spiral Non-Latex Contra Disposable Prophy Angle Soft Cup Box of 144 single use prophy angles for dental prophylaxis procedures

Preventech

Dental polishing cup, single-use

• Primary Device ID: D02411444433
• NIH Device Record Key: 5ab6716e-e92d-4cbc-a417-a401b7d54edc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIVOT Plus Spiral Non-Latex Contra Disposable Prophy Angle Soft Cup Box 144
• Version Model Number: 1144443
• Catalog Number: 1144443
• Company DUNS: 090735093
• Company Name: Preventech
• Device Count: 144
• 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	D0241144443 [Primary]
HIBCC	D02411444433 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951016

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

Devices Manufactured by Preventech

• D024772105 - VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 35: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 35 ea. 0.5mL unit dose packages
• D024772113 - VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 100: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box of 100 0.5mL unit dose packages
• D024772115 - VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 100: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 100 ea. 0.5mL unit dose packages
• D024772145 - VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 35: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 35 ea. 0.5mL unit dose packages
• D024772153 - VELLAmini 5% Sodium Fluoride Varnish Caramel Box 100: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Caramel Box of 100 0.5mL unit dose packages
• D024772155 - VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 100: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 100 0.5mL unit dose packages
• D024772215 - VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 35: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 35 ea. 0.5mL unit dose packages
• D024772225 - VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 35: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 35 ea. 0.5mL unit dose packages