Mizzy Millennium

Basic Information

• Brand Name: Mizzy Millennium
• Primary DI: H66860100431
• Version / Model: 6010043
• Catalog Number: 6010043
• Company Name: Keystone Industries
• Labeler DUNS: 073503117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 3
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: 991f584d-7fbb-4b14-9c31-2d92b0de3924

Device Description

Denture Acrylic QC Deep Veined 5 lb P& L

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11171	Denture repair kit, professional	A collection of devices used in dentistry by a dentist or dental laboratory technician to repair cracks or breaks in a denture. It will contain the necessary materials and components, e.g., resins, adhesives/glues, mixing utensils, and an applicator. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	H66860100431	HIBCC

Customer Contacts

• Phone: [phone] ext. 8455
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K983876	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 27 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 60 – 80 Degrees Fahrenheit