Prosthetic Accessories To The ITI Dental Implant System 010.6120

GUDID 07630031739261

WN synOcta® Cementable Abutment, H 5.5mm, Ti

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031739261
• NIH Device Record Key: 14a4e7c1-1f1b-4f35-9fa3-512e719521ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosthetic Accessories To The ITI Dental Implant System
• Version Model Number: Final Abutments
• Catalog Number: 010.6120
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com

Device Dimensions

• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031739261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013798

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

Sterilization

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

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

[07630031739261]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-22
• Device Publish Date: 2022-04-14

On-Brand Devices [Prosthetic Accessories To The ITI Dental Implant System]

• 07630031725233: WN synOcta® Cementable Abutment, H 5.5mm, Ti
• 07630031725219: WN synOcta® 1.5 screw-retained Abutment, H 1.5mm, TAN
• 07630031723680: WN synOcta® Post for temp. restoration, bridge, H 9mm, Ti
• 07630031723673: WN synOcta® Post, for temporary restoration, crown, H 9mm, Ti
• 07630031722478: WN healing cap, height 4.5 mm, titanium
• 07630031739261: WN synOcta® Cementable Abutment, H 5.5mm, Ti