Vortex

GUDID 00860014670206

Premilled Titanium Blank Z - WP 5.7

LOUISIANA DENTAL IMPLANT LAB LLC

Dental implant suprastructure, permanent, custom-made

• Primary Device ID: 00860014670206
• NIH Device Record Key: a388ce14-6f62-4e87-b4a5-d144da5273ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vortex
• Version Model Number: TiPreMillZ-5.7
• Company DUNS: 077666070
• Company Name: LOUISIANA DENTAL IMPLANT LAB LLC
• Device Count: 1
• DM Exempt: false
• 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: true
• 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	00860014670206 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-21
• Device Publish Date: 2025-11-13

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
• 00860014670244: Premilled Titanium Blank B - 5.7
• 00860014670237: Premilled Titanium Blank B - 4.5
• 00860014670220: Premilled Titanium Blank B - 3.5
• 00860014670206: Premilled Titanium Blank Z - WP 5.7
• 00860011853794: Premilled titanium blank Z - RP 4.5
• 00860011853787: Premilled Titanium Blank Z - NP 3.5
• 00860014670251: Dental Implant Screw 1.4mm - Bredent