GUDID 06009544013792

Peek Temporary Abutment, Non-Engaging, for TSA6

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 06009544013792
• NIH Device Record Key: 586dbccf-8807-4159-bb32-526f03f916e6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ITS6-TA
• 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	06009544013792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172160

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: 2019-02-25
• Device Publish Date: 2019-01-23

Devices Manufactured by SOUTHERN IMPLANTS (PTY) LTD

• 06009544040941 - N/A: 2024-05-20 Abutment Peek Temp Eng ø3.0 DC
• 06009544040958 - N/A: 2024-05-20 Abutment Peek Temp NE ø3.0 DC
• 06009544040965 - N/A: 2024-05-20 Abutment Peek Temp Eng ø4.0 DC
• 06009544040972 - N/A: 2024-05-20 Abutment Peek Temp NE ø3.5/4.0 DC
• 06009544040989 - N/A: 2024-05-20 Abutment Peek Temp Eng ø5.0 DC
• 06009544040996 - N/A: 2024-05-20 Abutment Peek Temp NE ø5.0 DC
• 06009544041009 - N/A: 2024-05-20 Abutment Peek Temp Eng ø3.5 TN
• 06009544041016 - N/A: 2024-05-20 Abutment Peek Temp NE ø3.5 TN