GDT Ball Attachment Abutment 5mm

GUDID D1500000SBA5

GLOBAL DENTAL TRANSFER LTD

Dental implant system

• Primary Device ID: D1500000SBA5
• NIH Device Record Key: 13719215-75be-4347-a161-aeb0c354ac51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GDT Ball Attachment Abutment 5mm
• Version Model Number: SBA5
• Company DUNS: 532376847
• Company Name: GLOBAL DENTAL TRANSFER LTD
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D1500000SBA5 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200188

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

[D1500000SBA5]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-01
• Device Publish Date: 2024-06-23

Devices Manufactured by GLOBAL DENTAL TRANSFER LTD

• 07290123172224 - IH Popup Transfer Abutment: 2026-01-29
• 07290123172231 - IH Popup Transfer Abutment: 2026-01-29
• 07290123172248 - IH Popup Transfer Abutment: 2026-01-29
• 07290123172255 - IH Popup Transfer Abutment: 2026-01-29
• 07290123172262 - IH Multi Unit Transfer Screw: 2026-01-29
• 07290123172279 - IH Transfer Screw: 2026-01-29
• 07290123172286 - IH Transfer Screw: 2026-01-29
• 07290123172293 - IH Transfer Screw: 2026-01-29