P.004 ABUTMENTS 022.4702

GUDID 07630031708915

RC Abutment, for bars, Ti

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031708915
• NIH Device Record Key: 8a5b8088-5162-46b1-89ad-2745d81be11d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.004 ABUTMENTS
• Version Model Number: Edentulous Abutments
• Catalog Number: 022.4702
• 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	07630031708915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071919

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031708915]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-09-24

On-Brand Devices [P.004 ABUTMENTS]

• 07630031710437: NC Temporary Abutment, D 5mm, H 12mm, PEEK/TAN
• 07630031710260: NC Healing Abutment, customizable, D 5mm, PEEK
• 07630031708915: RC Abutment, for bars, Ti
• 07630031708908: RC Abutment for bars, gold, H 10mm, Ceramicor®
• 07630031708144: NC Abutment, for bars, Ti
• 07630031708137: NC Abutment for bars, gold, H 10mm, Ceramicor®