Dentorium

Basic Information

• Brand Name: Dentorium
• Primary DI: 05056079040916
• Version / Model: Convertible CC 3kg Clear
• Catalog Number: AC2S05305
• Company Name: WRIGHT HEALTH GROUP LIMITED
• Labeler DUNS: 214045304
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 65c5f2a5-d110-40e1-9f02-ca36307a439b

Device Description

Cold Cure Denture Base Powder

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: 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
55831	Denture base resin kit	A collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually includes the resin monomer (e.g., acrylic monomer of methyl methacrylate), a catalyst intended for polymerization, and additional products such as pigments, plasticizers, and/or devices (e.g., flasks, clamps). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05056079040916	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K011820	000