Straumann Variobase for CEREC 022.0019

GUDID 07630031707727

RN Straumann® Variobase® C, TAN

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031707727
• NIH Device Record Key: 0f4a789e-0451-4190-bc66-6423d3f88741
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann Variobase for CEREC
• Version Model Number: Final Abutments
• Catalog Number: 022.0019
• 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(801)448-8168
• Email: info.usa@straumann.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031707727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151324

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031707727]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-05-16

On-Brand Devices [Straumann Variobase for CEREC]

• 07630031707833: Basal Screw RN/WN Variobase®, TAN
• 07630031707789: NC Straumann® Variobase® for CEREC®, TAN
• 07630031707772: RC Straumann® Variobase® for CEREC®, TAN
• 07630031707734: WN Straumann® Variobase® C, TAN
• 07630031707727: RN Straumann® Variobase® C, TAN