GDT Ball Attachment Abutment 6mm

GUDID D1500000SBA6

GLOBAL DENTAL TRANSFER LTD

Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system Dental implant system

• Primary Device ID: D1500000SBA6
• NIH Device Record Key: 72693da6-22b4-4231-80d6-7c850a24b2f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GDT Ball Attachment Abutment 6mm
• Version Model Number: SBA6
• 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	D1500000SBA6 [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

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

Moist Heat or Steam Sterilization

[D1500000SBA6]

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

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• D15000LIRP10 - GDT Click Attachment 1mm: 2024-07-02
• D15000LIRP20 - GDT Click Attachment 2mm: 2024-07-02
• D15000LIRP30 - GDT Click Attachment 3mm: 2024-07-02
• D15000LIRP40 - GDT Click Attachment 4mm: 2024-07-02
• D15000LIRP50 - GDT Click Attachment 5mm: 2024-07-02
• D15000LIRP60 - GDT Click Attachment 6mm: 2024-07-02
• D1500MUSRP10 - GDT Straight Multi-Unit 1.6mm - 1mm: 2024-07-02