Implant Club EVHA55

GUDID 00860012237340

Healing Abutment - Tall Ø 5.0 H 5.0

IMPLANT CLUB, INC

Dental implant system

• Primary Device ID: 00860012237340
• NIH Device Record Key: debecedd-51d7-4530-8767-8769df5b57cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Implant Club
• Version Model Number: 1
• Catalog Number: EVHA55
• Company DUNS: 131526459
• Company Name: IMPLANT CLUB, INC
• 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: false
• 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: 12092422977
• Email: theimplantclub@gmail.com
• Phone: 12092422977
• Email: theimplantclub@gmail.com
• Phone: 12092422977
• Email: theimplantclub@gmail.com
• Phone: 12092422977
• Email: theimplantclub@gmail.com
• Phone: 12092422977
• Email: theimplantclub@gmail.com
• Phone: 12092422977
• Email: theimplantclub@gmail.com
• Phone: 12092422977
• Email: theimplantclub@gmail.com
• Phone: 12092422977
• Email: theimplantclub@gmail.com
• Phone: 12092422977
• Email: theimplantclub@gmail.com
• Phone: 12092422977
• Email: theimplantclub@gmail.com
• Phone: 12092422977
• Email: theimplantclub@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012237340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143142

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00860012237340]

Moist Heat or Steam Sterilization

[00860012237340]

Moist Heat or Steam Sterilization

[00860012237340]

Moist Heat or Steam Sterilization

[00860012237340]

Moist Heat or Steam Sterilization

[00860012237340]

Moist Heat or Steam Sterilization

[00860012237340]

Moist Heat or Steam Sterilization

[00860012237340]

Moist Heat or Steam Sterilization

[00860012237340]

Moist Heat or Steam Sterilization

[00860012237340]

Moist Heat or Steam Sterilization

[00860012237340]

Moist Heat or Steam Sterilization

[00860012237340]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-12
• Device Publish Date: 2024-09-04

On-Brand Devices [Implant Club]

• 00860012237357: Healing Abutment - Wide Ø 6.0 H 3.0
• 00860012237340: Healing Abutment - Tall Ø 5.0 H 5.0
• 00860012237333: Healing Abutment - Regular Ø 5.0 H 3.0
• 00860012237326: Healing Abutment - Skinny Ø 4.0 H 3.0
• 00860012237319: Closed Tray Impression Coping Straight Transfer Abutment L - 2mm
• 00860012237302: Open Tray Impression Coping Standard Open Transfer 13mm