IDI Dental Implant IDI-1035-105-A

GUDID D747IDI1035105A1

IDI Implant Fixture 3.5mm x 10.5mm (Practice Building Kit)

AIDI BIOMEDICAL LLC

Dental implant system

• Primary Device ID: D747IDI1035105A1
• NIH Device Record Key: 1f8037a5-8e13-4bc3-8fa7-2ca930041527
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IDI Dental Implant
• Version Model Number: IDI-1035-105-A
• Catalog Number: IDI-1035-105-A
• Company DUNS: 029453028
• Company Name: AIDI BIOMEDICAL 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 1-951-678-9626
• Email: support@aidibiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D747IDI1035105A1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081806

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-27
• Device Publish Date: 2019-05-17

On-Brand Devices [IDI Dental Implant]

• D747IDI1035105A1: IDI Implant Fixture 3.5mm x 10.5mm (Practice Building Kit)
• D747IDI1035088A1: IDI Implant Fixture 3.5mm x 8.8mm (Practice Building Kit)