Prophy Brush

Basic Information

• Brand Name: Prophy Brush
• Primary DI: 08806383525756
• Version / Model: Pointed Head, Latch Type
• Catalog Number: 950-111
• Company Name: DiaDent Group International
• Labeler DUNS: 687789453
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-13
• Public Version: 1
• Public Version Date: 2020-08-21
• Public Version Status: New
• Public Device Record Key: 54bc24a8-c164-4be3-8fbb-e9fdbe4e0e13

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
Primary	08806383525756	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry and Keep away from Sunlight.