GoDirect® Implant Comfort Cap 4500-26

GUDID 00841307129809

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00841307129809
• NIH Device Record Key: 0ca705d5-85f9-4e85-95a1-e8be97f0650c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoDirect® Implant Comfort Cap
• Version Model Number: 4500-26
• Catalog Number: 4500-26
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING LLC
• Device Count: 2
• 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: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com
• Phone: 1-888-649-6425
• Email: customerservice@implantdirect.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841307129809 [Unit of Use]
GS1	10841307129806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090234

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

[00841307129809]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-20
• Device Publish Date: 2024-03-12

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

• 00841307129519 - Long Fixation Screw: 2024-03-20
• 00841307129526 - Dual-Grip™ Long Fixation Screw: 2024-03-20
• 00841307129533 - Dual-Grip™ Long Fixation Screw: 2024-03-20
• 00841307129540 - Long Fixation Screw: 2024-03-20
• 00841307129557 - Fixation Screw: 2024-03-20
• 00841307129571 - Duo-Grip™ Long Fixation Screw: 2024-03-20
• 00841307129588 - Duo-Grip™ Fixation Screw: 2024-03-20
• 00841307129595 - Duo-Grip™ Fixation Screw Extra Short: 2024-03-20