Vortex

GUDID 00198168629031

Dental Implant Screw

LOUISIANA DENTAL IMPLANT LAB LLC

Dental prosthesis/implant abutment screw analog, reusable

• Primary Device ID: 00198168629031
• NIH Device Record Key: ca78334e-ed42-431c-8de1-5830970a71ba
• Commercial Distribution Discontinuation: 2025-01-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vortex
• Version Model Number: 1.4mm Screw
• Company DUNS: 077666070
• Company Name: LOUISIANA DENTAL IMPLANT LAB LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00198168629031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961384

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2025-01-13
• Device Publish Date: 2024-07-11

On-Brand Devices [Vortex]

• 00198168629031: Dental Implant Screw
• 00860011853749: Dental Implant Screw 1.4mm
• 00860011853725: Dental Implant Screw
• 00860011853701: Dental Implant Screw
• 00860011853770: Angled MUA Abutment 30° 4.5*3.0mmH
• 00860011853763: Angled MUA Abutment 17° 4.5*2.0mmH
• 00860011853756: Angled MUA Abutment 30° 3.5*3.0mmH
• 00860011853732: Angled MUA Abutment 17° 3.5*2mmH