GDT MOR Spiral Implant 3.75 x 10mm

GUDID D1500SPI1038

GLOBAL DENTAL TRANSFER LTD

Dental implant system

• Primary Device ID: D1500SPI1038
• NIH Device Record Key: 2e5d2adc-fbdb-4eaf-ba69-d602b88f89ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GDT MOR Spiral Implant 3.75 x 10mm
• Version Model Number: SPI1038
• 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	D1500SPI1038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200188

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: 2024-06-26
• Device Publish Date: 2024-06-18

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