PIVOT Non-Latex Disposable Prophy Angle Soft Cup Box 144 1100013

GUDID D02411000133

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

Preventech

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• Primary Device ID: D02411000133
• NIH Device Record Key: 31853ff3-8551-4c56-b0f9-393ede8c79b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIVOT Non-Latex Disposable Prophy Angle Soft Cup Box 144
• Version Model Number: 1100013
• Catalog Number: 1100013
• 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	D0241100013 [Primary]
HIBCC	D02411000133 [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

• D02411000133 - PIVOT Non-Latex Disposable Prophy Angle Soft Cup Box 144: 2023-06-21PIVOT Non-Latex Disposable Prophy Angle Soft Cup Box of 144 single use prophy angles for dental prophylaxis procedures
• D02411000133 - PIVOT Non-Latex Disposable Prophy Angle Soft Cup Box 144: 2023-06-21 PIVOT Non-Latex Disposable Prophy Angle Soft Cup Box of 144 single use prophy angles for dental prophylaxis procedures
• D02411000233 - PIVOT Non-Latex Disposable Prophy Angle Firm Cup Box 144: 2023-06-21 PIVOT Non-Latex Disposable Prophy Angle Firm Cup Box of 144 single use prophy angles for dental prophylaxis procedures
• D02411000333 - PIVOT Non-Latex Disposable Prophy Angle Taper Brush Box 144: 2023-06-21 PIVOT Non-Latex Disposable Prophy Angle Taper Brush Box of 144 single use taper brushes for dental procedures
• D02411000433 - PIVOT Non-Latex Disposable Prophy Angle NL Soft Cup Box 144: 2023-06-21 PIVOT Non-Latex Disposable Prophy Angle NL Soft Cup Box of 144 single use prophy angles for dental prophylaxis procedures
• D02411000533 - PIVOT Non-Latex Disposable Prophy Angle NL Firm Cup Box 144: 2023-06-21 PIVOT Non-Latex Disposable Prophy Angle NL Firm Cup Box of 144 single use prophy angles for dental prophylaxis procedures
• D02411000633 - PIVOT Fine Cherry Prophy Pack Box 100: 2023-06-21 PIVOT Fine Cherry Prophy Pack Box of 100 units each containing 1 Pivot Non-Latex Prophy Angle Soft Cup and 1 2.0g prophy cup of
• D02411000733 - PIVOT Medium Mint Prophy Pack Box 100: 2023-06-21 PIVOT Medium Mint Prophy Pack Box of 100 units each containing 1 PIVOT Non-Latex Prophy Angle Soft Cup and 1 2.0g prophy cup of
• D02411000833 - PIVOT Coarse Mint Prophy Pack Box 100: 2023-06-21 PIVOT Coarse Mint Prophy Pack Box of 100 units each containing 1 PIVOT Non-Latex Prophy Angle Soft Cup and 1 2.0g prophy cup of