TLX SRAs And TLX Gold Abutments 037.2301

GUDID 07630031755209

WT Gold Abutment, bridge, H 4mm, Ceramicor®/POM

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

• Primary Device ID: 07630031755209
• NIH Device Record Key: 40bd0e02-0d1d-4e81-9287-871b55dde451
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TLX SRAs And TLX Gold Abutments
• Version Model Number: Final Abutments
• Catalog Number: 037.2301
• 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: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 Millimeter
• Height: 4 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	07630031755209 [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

[07630031755209]

Moist Heat or Steam Sterilization

[07630031755209]

Moist Heat or Steam Sterilization

[07630031755209]

Moist Heat or Steam Sterilization

[07630031755209]

Moist Heat or Steam Sterilization

[07630031755209]

Moist Heat or Steam Sterilization

[07630031755209]

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