Dentorium

Basic Information

• Brand Name: Dentorium
• Primary DI: 05056079042149
• Version / Model: Lower Single Pink x12
• Catalog Number: DS701
• Company Name: WRIGHT HEALTH GROUP LIMITED
• Labeler DUNS: 214045304
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-13
• Public Version: 1
• Public Version Date: 2018-05-14
• Public Version Status: New
• Public Device Record Key: afbd0d52-9c12-4cf3-832c-e2c36551f1d9

Device Description

Base Plates / Special Impression Tray Blanks. Shellac resin. Single thickness. Pink. Lower.

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: 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
EBH	Material, Impression Tray, Resin	Dental	872.3670	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34808	Dental base plate	A foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05056079042149	GS1

Customer Contacts

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