SMARTbase ScrewIndirect® Cylinder 4000-69B

GUDID 10841307123491

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 10841307123491
• NIH Device Record Key: 4e8fe6bc-1a8a-474b-a259-56531bf7c56c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTbase ScrewIndirect® Cylinder
• Version Model Number: 4000-69B
• Catalog Number: 4000-69B
• Company DUNS: 868856969
• Company Name: IMPLANT DIRECT SYBRON MANUFACTURING 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841307123491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223535

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

[10841307123491]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-07
• Device Publish Date: 2023-08-30

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

• 10841307131014 - DIRECTguide™ Guided Surgery Kit - Empty: 2024-05-28
• 10841307131021 - DIRECTguide™ Guided Surgery Kit - Legacy: 2024-05-28
• 10841307131038 - DIRECTguide™ Guided Surgery Kit - Conical: 2024-05-28
• 10841307131045 - DIRECTguide™ Guided Step Drill: 2024-05-28
• 10841307131052 - DIRECTguide™ Guided Step Drill: 2024-05-28
• 10841307131069 - DIRECTguide™ Guided Step Drill: 2024-05-28
• 10841307131076 - DIRECTguide™ Guided Step Drill: 2024-05-28
• 10841307131083 - DIRECTguide™ Guided Step Drill: 2024-05-28