Passive Abutment

GUDID 06009544014072

Passive Abutment, Non-Engaging, for IT Ø4.8 Interface

SOUTHERN IMPLANTS (PTY) LTD

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06009544014072
• NIH Device Record Key: 8e1ba1cc-dc53-403e-bd0b-7b44eb7f451e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Passive Abutment
• Version Model Number: ITS-PA-NE
• 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	06009544014072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061169

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

Moist Heat or Steam Sterilization

[06009544014072]

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: 2019-01-23

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