Straumann TLX Implant System 010.6142

GUDID 07630031747259

NT/RT/WT SRBB Basal Screw AS, TAN, 036.3111

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: 07630031747259
• NIH Device Record Key: 005684fa-6ce6-4f36-99ab-38a5f040c88f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann TLX Implant System
• Version Model Number: Screws
• Catalog Number: 010.6142
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	07630031747259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200586

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

Sterilization

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

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

[07630031747259]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-22
• Device Publish Date: 2022-04-14

On-Brand Devices [Straumann TLX Implant System]

• 07630031747259: NT/RT/WT SRBB Basal Screw AS, TAN, 036.3111
• 07630031747242: NT/RT/WT SRBB Basal Screw, TAN, 036.3110
• 07630031746221: NT/RT/WT Basal Screw AS, TAN
• 07630031746214: NT/RT/WT Basal Screw, TAN