PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM 048.233

GUDID 07630031723673

WN synOcta® Post, for temporary restoration, crown, H 9mm, Ti

Institut Straumann AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07630031723673
• NIH Device Record Key: def39d37-79ba-4bc4-8809-0c2d0a1ae23a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
• Version Model Number: Temporary Abutments
• Catalog Number: 048.233
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• 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: 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031723673 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013798

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[07630031723673]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-04
• Device Publish Date: 2015-09-24

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