ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM 048.561

GUDID 07630031725028

WN synOcta® Meso Abutment, for crown, D 10mm, Ti

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031725028
• NIH Device Record Key: 7c09ed8f-8111-4a2e-a258-0e2cc962308f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
• Version Model Number: Final Abutments
• Catalog Number: 048.561
• 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

• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031725028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020096

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[07630031725028]

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 [ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM]

• 07630031725028: WN synOcta® Meso Abutment, for crown, D 10mm, Ti
• 07630031725011: RN synOcta® Meso Abutment, for crown, D 8mm, Ti