Straumann TLX Implant System 036.3110

GUDID 07630031746214

NT/RT/WT Basal Screw, TAN

Institut Straumann AG

Dental prosthesis/implant abutment screw

• Primary Device ID: 07630031746214
• NIH Device Record Key: 3d08bfd6-9d4c-4625-849e-f8140a259250
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann TLX Implant System
• Version Model Number: Screws
• Catalog Number: 036.3110
• 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(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031746214 [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

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

[07630031746214]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-21
• Device Publish Date: 2020-11-06

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