STRAUMANN (C.A.R.E.S.) CERAMIC COPING 048.777

GUDID 07630031728906

RN Screw for CARES® Abutment, ZrO2 , and instructions for use

Institut Straumann AG

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031728906
• NIH Device Record Key: 1f68d3f9-746b-4578-9e05-1f2ba27afefe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRAUMANN (C.A.R.E.S.) CERAMIC COPING
• Version Model Number: Final Abutments
• Catalog Number: 048.777
• 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
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031728906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061277

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

Moist Heat or Steam Sterilization

[07630031728906]

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 [STRAUMANN (C.A.R.E.S.) CERAMIC COPING]

• 07630031728937: RN Occlusal screw, for ceramic abutment only, TAN
• 07630031728906: RN Screw for CARES® Abutment, ZrO2 , and instructions for use
• 07630031728852: RN Occlusal screw, for ceramic abutment only, TAN
• 07630031724229: RN Occlusal screw, for ceramic only, L 5 mm, TAN
• 07630031717733: RN Straumann® CARES® Abutment, set ZrO2 / TAN