PIVOT Non-Latex Disposable Prophy Angle Taper Brush Box 144

Basic Information

• Brand Name: PIVOT Non-Latex Disposable Prophy Angle Taper Brush Box 144
• Primary DI: D0241100033
• Version / Model: 1100033
• Catalog Number: 1100033
• Company Name: Preventech
• Labeler DUNS: 090735093
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 144
• Record Status: Published
• Publish Date: 2023-06-13
• Public Version: 1
• Public Version Date: 2023-06-21
• Public Version Status: New
• Public Device Record Key: 6810f1c6-3523-4418-b73b-fa66b8af0638

Device Description

PIVOT Non-Latex Disposable Prophy Angle Taper Brush Box of 144 single use taper brushes for dental procedures

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHK	Cup, Prophylaxis	Dental	872.6290	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64015	Dental-professional prophylaxis brush, single-use	A non-sterile rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D02411000333	HIBCC
Primary	D0241100033	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K951016	000