ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM 048.638

GUDID 07630031725448

WN synOcta® gold coping, bridge for synOcta 1.5, H 4.75mm, Ceramicor®/POM

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031725448
• NIH Device Record Key: 17f1e437-eb33-403d-bd36-bed47ec73aee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
• Version Model Number: Final Copings
• Catalog Number: 048.638
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031725448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022859

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[07630031725448]

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 [ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM]

• 07630031725455: WN synOcta® gold coping, crown for synOcta 1.5, H 4.75mm, Ceramicor®/POM
• 07630031725448: WN synOcta® gold coping, bridge for synOcta 1.5, H 4.75mm, Ceramicor®/POM
• 07630031725424: NN Gold coping, cast-on, H 10mm, Ceramicor®/POM
• 07630031725400: RN synOcta® gold coping, crown, for 048.602, H 4.25mm, Ceramicor®/POM
• 07630031725394: RN synOcta® gold coping, bridge, for synOcta 1.5, H 4.25mm, Ceramicor®/POM
• 07630031725202: RN synOcta® 1.5 screw-retained Abutment, H 1.5mm, Ti
• 07630031723741: RN synOcta® Milling Cylinder, Bridge, for synOcta® 1.5, D 6mm, H 8mm, Ti