GUDID 06009544013402

Internal Octagon Cylindrical Implant, Ø4.8 Platform, Ø4.9 x 8mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544013402
• NIH Device Record Key: 0f6fa64f-592c-4329-ae84-c03efecd51aa
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ITC508
• Company DUNS: 636239584
• Company Name: SOUTHERN IMPLANTS (PTY) 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: false
• 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
GS1	06009544013402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061169

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: 2019-02-11
• Device Publish Date: 2019-01-10

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• 06009544048718 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x40mm
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• 06009544048732 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x45mm
• 06009544048749 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x47.5mm