Straumann BLX Ø3.5 mm Implants 061.3312

GUDID 07630031743299

BLX Implant, Ø 3.5mm RB, SLActive® 12mm, Roxolid®

Institut Straumann AG

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• Primary Device ID: 07630031743299
• NIH Device Record Key: 3bb5114a-1c7b-49ed-b2ad-a800cb7cf097
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann BLX Ø3.5 mm Implants
• Version Model Number: SLActive Roxolid BL
• Catalog Number: 061.3312
• 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
• 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 Dimensions

• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 3.5 Millimeter
• Length: 12 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
• 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
• 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	07630031743299 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191256

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

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 BLX Ø3.5 mm Implants]

• 07630031743398: BLX Implant, Ø 3.5mm RB, SLA® 18mm, Roxolid®
• 07630031743381: BLX Implant, Ø 3.5mm RB, SLA® 16mm, Roxolid®
• 07630031743374: BLX Implant, Ø 3.5mm RB, SLA® 14mm, Roxolid®
• 07630031743367: BLX Implant, Ø 3.5mm RB, SLA® 12mm, Roxolid®
• 07630031743350: BLX Implant, Ø 3.5mm RB, SLA® 10mm, Roxolid®
• 07630031743343: BLX Implant, Ø 3.5mm RB, SLA® 8mm, Roxolid®
• 07630031743329: BLX Implant, Ø 3.5mm RB, SLActive® 18mm, Roxolid®
• 07630031743312: BLX Implant, Ø 3.5mm RB, SLActive® 16mm, Roxolid®
• 07630031743305: BLX Implant, Ø 3.5mm RB, SLActive® 14mm, Roxolid®
• 07630031743299: BLX Implant, Ø 3.5mm RB, SLActive® 12mm, Roxolid®
• 07630031743282: BLX Implant, Ø 3.5mm RB, SLActive® 10mm, Roxolid®
• 07630031743275: BLX Implant, Ø 3.5mm RB, SLActive® 8mm, Roxolid®