Vitallium® N001230

GUDID D001N001230

Dentsply International Inc.

Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material Subperiosteal dental implant material

• Primary Device ID: D001N001230
• NIH Device Record Key: 6d968fba-bca7-4671-844f-3e48a5bb09e5
• Commercial Distribution Discontinuation: 2022-06-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vitallium®
• Version Model Number: Special Alloy
• Catalog Number: N001230
• Company DUNS: 606173334
• Company Name: Dentsply International Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com
• Phone: +1(800)243-1942
• Email: Prosthetics-Regulatory@dentsply.com

Device Dimensions

• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram
• Weight: 500 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D001N001230 [Primary]

FDA Product Code

• ELE: IMPLANT, SUBPERIOSTEAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-13
• Device Publish Date: 2018-06-30

On-Brand Devices [Vitallium®]

• D001N0410050: Nickel-Free Welding Rod
• D001N0017000: 5 Alloy
• D001N0014350: 2 Alloy
• D001N0013350: III Alloy
• D001N0012300: Special Alloy
• D001N001230: Special Alloy