Straumann CARES M-Series CAD/CAM System 048.829

GUDID 07630031729637

WN Pre-milled Abutment Blank, for CARES®, Ø 12mm, TAN

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031729637
• NIH Device Record Key: f69fed98-e792-4626-ad50-40c0485b8dbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann CARES M-Series CAD/CAM System
• Version Model Number: Final Abutments
• Catalog Number: 048.829
• 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 Dimensions

• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031729637 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171649

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031729637]

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: 2019-06-18

On-Brand Devices [Straumann CARES M-Series CAD/CAM System]

• 07630031729637: WN Pre-milled Abutment Blank, for CARES®, Ø 12mm, TAN
• 07630031729620: RN Pre-milled Abutment Blank, for CARES®, Ø 12mm, TAN
• 07630031729569: RC Pre-milled Abutment Blank, for CARES®, Ø 12mm, TAN
• 07630031729552: NC Pre-milled Abutment Blank, for CARES®, Ø 12mm, TAN
• 07630031740809: WB Pre-milled Abutment Blank, for CARES®, Ø 12mm, TAN
• 07630031740762: RB/WB Pre-milled Abutment Blank, for CARES®, Ø 12mm, TAN
• 07630031755261: WT Pre-milled Abutment Blank, for CARES®, Ø 12mm, TAN
• 07630031755254: RT Pre-milled Abutment Blank, for CARES®, Ø 12mm, TAN
• 07630031755247: NT Pre-milled Abutment Blank, for CARES®, Ø 12mm, TAN