Confident, MDC Dental

Basic Information

• Brand Name: Confident, MDC Dental
• Primary DI: 07506338303538
• Version / Model: Denture Adhesive Powder
• Company Name: MDC DENTAL
• Labeler DUNS: 811180298
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-28
• Public Version: 1
• Public Version Date: 2022-10-06
• Public Version Status: New
• Public Device Record Key: 2247e39c-4ed9-46f9-8a1f-253e50d1189f

Device Description

Confident. Denture Adhesive Powder. Container with 0.7 OZ (20 g).

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: Yes
• 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
KOT	Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium	Dental	872.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46125	Carboxymethylcellulose sodium denture adhesive	An adhesive compound composed of carboxymethylcellulose sodium (usually 40 to 100%) used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07506338303538	GS1

Customer Contacts

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