Vitallium®

Basic Information

• Brand Name: Vitallium®
• Primary DI: D001N001230
• Version / Model: Special Alloy
• Catalog Number: N001230
• Company Name: Dentsply International Inc.
• Labeler DUNS: 606173334
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-30
• Public Version: 2
• Public Version Date: 2023-02-13
• Public Version Status: Update
• Public Device Record Key: 6d968fba-bca7-4671-844f-3e48a5bb09e5
• Distribution End Date: 2022-06-03

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELE	IMPLANT, SUBPERIOSTEAL	Dental	872.3645	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42352	Subperiosteal dental implant material	A non-sterile material intended to be used, typically within a dental laboratory, to create a subperiosteal dental implant. It is typically in the form of a metallic ingot (e.g., titanium, cobalt-chrome-molybdenum) intended to be custom moulded for surgical implantation between the periosteum and the surface of the bone (subperiosteal frame) to provide support and a means of retention for a dental prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D001N001230	HIBCC

Customer Contacts

• Phone: [phone] ext. 54660
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	500	Gram