STRAUMANN (C.A.R.E.S.) CERAMIC COPING 048.359-04

GUDID 07630031728852

RN Occlusal screw, for ceramic abutment only, TAN

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031728852
• NIH Device Record Key: 9a8e4063-ad00-4083-a7f1-5663f381f025
• Commercial Distribution Discontinuation: 2019-02-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: STRAUMANN (C.A.R.E.S.) CERAMIC COPING
• Version Model Number: 1
• Catalog Number: 048.359-04
• 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	07630031728852 [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

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

Moist Heat or Steam Sterilization

[07630031728852]

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