BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants 061.9516

GUDID 07630031755438

BLX Implant, Ø 6.5mm WB, SLA® 16mm, Roxolid®

Institut Straumann AG

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• Primary Device ID: 07630031755438
• NIH Device Record Key: 8ca5928c-6185-4b78-8c42-a8ff903f86cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
• Version Model Number: SLA Roxolid BL
• Catalog Number: 061.9516
• 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(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 Dimensions

• Outer Diameter: 6.5 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 6.5 Millimeter
• Length: 16 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031755438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212533

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: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants]

• 07630031755438: BLX Implant, Ø 6.5mm WB, SLA® 16mm, Roxolid®
• 07630031755421: BLX Implant, Ø 6.5mm WB, SLA® 14mm, Roxolid®
• 07630031755414: BLX Implant, Ø 6.5mm WB, SLActive® 16mm, Roxolid®
• 07630031755407: BLX Implant, Ø 6.5mm WB, SLActive® 14mm, Roxolid®
• 07630031755391: BLX Implant, Ø 5.5mm WB, SLA® 16mm, Roxolid®
• 07630031755384: BLX Implant, Ø 5.5mm WB, SLA® 14mm, Roxolid®
• 07630031755377: BLX Implant, Ø 5.5mm WB, SLActive® 16mm, Roxolid®
• 07630031755360: BLX Implant, Ø 5.5mm WB, SLActive® 14mm, Roxolid®
• 07630031743848: BLX Implant, Ø 5.0mm WB, SLA® 18mm, Roxolid®