Vortex

Basic Information

• Brand Name: Vortex
• Primary DI: 00198168629031
• Version / Model: 1.4mm Screw
• Company Name: LOUISIANA DENTAL IMPLANT LAB LLC
• Labeler DUNS: 077666070
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-11
• Public Version: 2
• Public Version Date: 2025-01-13
• Public Version Status: Update
• Public Device Record Key: ca78334e-ed42-431c-8de1-5830970a71ba
• Distribution End Date: 2025-01-10

Device Description

Dental Implant Screw

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
DZE	Implant, Endosseous, Root-Form	Dental	872.3640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61646	Dental prosthesis/implant abutment screw analog, reusable	A device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Also known as guide pin, it may also be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00198168629031	GS1

Premarket Submissions

Submission Number	Supplement Number
K961384	000