Vitallium® N001230

GUDID D001N001230

Dentsply International Inc.

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