DawnMist

Basic Information

• Brand Name: DawnMist
• Primary DI: 00665973010878
• Version / Model: DEN6283
• Catalog Number: DEN6283
• Company Name: Dukal LLC
• Labeler DUNS: 791014871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 40
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 1
• Public Version Date: 2022-12-14
• Public Version Status: New
• Public Device Record Key: 33b84a4f-18e8-43a2-9968-33648660f643

Device Description

Denture Tablets

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EFT	CLEANSER, DENTURE, OVER THE COUNTER	Dental	872.3520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35871	Denture cleanser	An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20665973010872	GS1	Case	24	In Commercial Distribution
Primary	00665973010878	GS1
Unit of Use	10665973010875	GS1

Customer Contacts

• Phone: [phone] ext. 172
• Email: [email protected]