GUDID 06009544021087

Healing Abutment for Ø4.0 Ex Hex, Ø4.5 x 3mm

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 06009544021087
• NIH Device Record Key: 3565f2c8-cb76-4c1a-ac79-723d4ae53515
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: TB3
• 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	06009544021087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163634

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

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: 2019-02-18
• Device Publish Date: 2019-01-17

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

• 06009544048671 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x30mm
• 06009544048688 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x32.5mm
• 06009544048695 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x35mm
• 06009544048701 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x37.5mm
• 06009544048718 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x40mm
• 06009544048725 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x42.5mm
• 06009544048732 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x45mm
• 06009544048749 - NA: 2024-12-19 Implant ExHex Wide ZYGIN Ø4.3x47.5mm