Straumann Bone Level Tapered Implants 021.3318

GUDID 07630031729842

BLT Ø3.3 NC, SLActive® 18mm, TiZr, Loxim

Institut Straumann AG

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• Primary Device ID: 07630031729842
• NIH Device Record Key: be65dc50-68e6-4fa5-8249-aea89fab5c83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann Bone Level Tapered Implants
• Version Model Number: 1
• Catalog Number: 021.3318
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• 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

• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter
• Length: 18 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031729842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153758

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-13

On-Brand Devices [Straumann Bone Level Tapered Implants]

• 07630031729927: BLT Ø4.8mm RC, SLA® 18mm, TiZr, Loxim
• 07630031729903: BLT Ø4.8 RC, SLActive® 18mm, TiZr, Loxim
• 07630031729897: BLT Ø4.1mm RC, SLA® 18mm, TiZr, Loxim
• 07630031729873: Bone Level Tapered Implant, D4.1mm RC, SLActive® 18mm, Roxolid®, Loxim™
• 07630031729866: Bone Level Tapered Implant, D3.3mm NC, SLA® 18mm, Roxolid®, Loxim™
• 07630031729842: BLT Ø3.3 NC, SLActive® 18mm, TiZr, Loxim