PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT S 048.375

GUDID 07630031724458

WN closure screw, small, titanium

Institut Straumann AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07630031724458
• NIH Device Record Key: 1c79dd71-218f-4fde-a15c-919de5cea097
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT S
• Version Model Number: 1
• Catalog Number: 048.375
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07630031724458 [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

[07630031724458]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2015-09-24

On-Brand Devices [PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT S]

• 07630031724458: WN closure screw, small, titanium
• 07630031723772: WN synOcta® Plastic Coping for 048.606, for bridge, H 7.35mm, POM
• 07630031723765: WN synOcta® Plastic Coping for 048.606, for crown, H 7.35mm, POM
• 07630031722263: WN healing cap, with labial bevel, height 2.0 mm, titanium