Passive Abutment

GUDID 06009544020561

Passive Abutment, Engaging, for Ø3.0 IP Ex Hex

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544020561
• NIH Device Record Key: f4f8202a-667e-42a0-99cd-ea90549f7a96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Passive Abutment
• Version Model Number: SP16
• 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	06009544020561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173706

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

[06009544020561]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-01-17

On-Brand Devices [Passive Abutment]

• 06009544020585: Vertical Passive Abutment, Engaging, for Ø3.0 IP Ex Hex
• 06009544020578: Passive Abutment, Non-Engaging, for Ø3.0 IP Ex Hex
• 06009544020561: Passive Abutment, Engaging, for Ø3.0 IP Ex Hex
• 06009544019817: Vertical Passive Abutment, Non-Engaging, for Ø4.0 Ex Hex
• 06009544019800: Vertical Passive Abutment, Engaging, for Ø4.0 Ex Hex
• 06009544019480: Passive Abutment, Non-Engaging, for Ø4.0 Ex Hex
• 06009544019442: Passive Abutment, Engaging, for Ø4.0 Ex Hex
• 06009544018247: Passive Abutment, Non-Engaging, for Ø5.0 DC
• 06009544018230: Passive Abutment, Non-Engaging, for Ø3.5 / Ø4.0 DC
• 06009544018223: Passive Abutment, Non-Engaging, for Ø3.0 DC
• 06009544018162: Passive Abutment for Ø4.8 Compact Conical
• 06009544017998: Passive Abutment, Engaging, for Ø6.0 Tri-Nex
• 06009544017967: Passive Abutment, Engaging, for Ø5.0 Tri-Nex
• 06009544017936: Passive Abutment, Engaging, for Ø4.3 Tri-Nex
• 06009544017905: Passive Abutment, Engaging, for Ø3.5 Tri-Nex
• 06009544017899: Passive Abutment, Engaging, for Ø5.0 DC
• 06009544017882: Passive Abutment, Engaging, for Ø3.5 / Ø4.0 DC
• 06009544017875: Passive Abutment, Engaging, for Ø3.0 DC
• 06009544014072: Passive Abutment, Non-Engaging, for IT Ø4.8 Interface
• 06009544014065: Passive Abutment, Engaging, for IT Ø4.8 Interface
• 06009544013716: Passive Abutment, Non-Engaging, for IT Ø6.5 Interface
• 06009544013709: Passive Abutment, Engaging, for IT Ø6.5 Interface