Denture Brushes

Basic Information

• Brand Name: Denture Brushes
• Primary DI: 00616784486024
• Version / Model: 4860
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 144
• Record Status: Published
• Publish Date: 2022-05-04
• Public Version: 2
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 42b0acec-81ea-4e99-b592-d98d17d8018c

Device Characteristics

• Single Use: No
• 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: 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
EFW	Toothbrush, Manual	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34879	Dental prosthesis/orthodontic appliance cleaning brush	A hand-held instrument comprised of a proximal handle and distal bristles intended to be used to manually clean a removable dental prosthesis (e.g., denture) and/or orthodontic appliance (e.g., retainer, aligner). It is intended to be used in the home and healthcare facility. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00616784486017	GS1
Primary	00616784486024	GS1
Package	00616784486031	GS1	Case	10	In Commercial Distribution