TLX SRAs And TLX Gold Abutments 037.1300

GUDID 07630031755162

RT Gold Abutment, crown, H 3.6mm, Ceramicor®/POM

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031755162
• NIH Device Record Key: 804d3aad-0335-48ec-8c9a-f9105d22d0cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLX SRAs And TLX Gold Abutments
• Version Model Number: Final Abutments
• Catalog Number: 037.1300
• 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: true
• Expiration Date: true
• 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

Device Dimensions

• Height: 3.6 Millimeter
• Height: 3.6 Millimeter
• Height: 3.6 Millimeter
• Height: 3.6 Millimeter
• Height: 3.6 Millimeter
• Height: 3.6 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031755162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213063

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

Sterilization

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

[07630031755162]

Moist Heat or Steam Sterilization

[07630031755162]

Moist Heat or Steam Sterilization

[07630031755162]

Moist Heat or Steam Sterilization

[07630031755162]

Moist Heat or Steam Sterilization

[07630031755162]

Moist Heat or Steam Sterilization

[07630031755162]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-18
• Device Publish Date: 2022-05-10

On-Brand Devices [TLX SRAs And TLX Gold Abutments]

• 07630031755209: WT Gold Abutment, bridge, H 4mm, Ceramicor®/POM
• 07630031755193: RT Gold Abutment, bridge, H 3.6mm, Ceramicor®/POM
• 07630031755186: NT Gold Abutment, bridge, H 3mm, Ceramicor®/POM
• 07630031755179: WT Gold Abutment, crown, H 4mm, Ceramicor®/POM
• 07630031755162: RT Gold Abutment, crown, H 3.6mm, Ceramicor®/POM
• 07630031755155: NT Gold Abutment, crown, H 3mm, Ceramicor®/POM
• 07630031755148: NT Screw-retained Abutment, angled 30°, AH 3.5mm, TAN
• 07630031755131: NT Screw-retained Abutment, angled 17°, AH 3.5mm, TAN