Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA 064.4361

GUDID 07630031759252

RB/WB Temporary Abutment, Ø 3.8mm, GH 1.5mm, VITA CAD-Temp/TAN

Institut Straumann AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07630031759252
• NIH Device Record Key: ad69fd7c-81b8-4de5-9051-7b9ba9111c5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
• Version Model Number: Temporary Abutments
• Catalog Number: 064.4361
• 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

Device Dimensions

• Height: 1.5 Millimeter
• Outer Diameter: 3.8 Millimeter
• Height: 1.5 Millimeter
• Outer Diameter: 3.8 Millimeter
• Height: 1.5 Millimeter
• Outer Diameter: 3.8 Millimeter
• Height: 1.5 Millimeter
• Outer Diameter: 3.8 Millimeter
• Height: 1.5 Millimeter
• Outer Diameter: 3.8 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031759252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220751

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-21
• Device Publish Date: 2022-06-10

On-Brand Devices [Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA]

• 07630031759276: WB Temporary Abutment, Ø 5.5mm, GH 1.5mmm, VITA CAD-Temp/TAN
• 07630031759269: RB/WB Temporary Abutment, Ø 4.5mm, GH 1.5mm, VITA CAD-Temp/TAN
• 07630031759252: RB/WB Temporary Abutment, Ø 3.8mm, GH 1.5mm, VITA CAD-Temp/TAN