GDT Standard Healing Cap 5mm

GUDID D150000SHC5

GLOBAL DENTAL TRANSFER LTD

Dental implant system

• Primary Device ID: D150000SHC5
• NIH Device Record Key: 5c2559b1-36db-432c-88e2-d83ebc230301
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GDT Standard Healing Cap 5mm
• Version Model Number: SHC5
• 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	D150000SHC5 [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

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

[D150000SHC5]

Moist Heat or Steam Sterilization

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

• D15000LIRP05 - GDT Click Attachment Assortment: 2024-07-02
• 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