BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 1 021.4312

GUDID 07630031706874

Bone Level Implant D 4.1mm RC, SLActive® 12mm, Roxolid® Loxim™

Institut Straumann AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07630031706874
• NIH Device Record Key: cbda0427-b086-438b-a0c4-d7fd5d4953db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 1
• Version Model Number: 1
• Catalog Number: 021.4312
• 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

Device Dimensions

• Length: 12 Millimeter
• Outer Diameter: 4.1 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031706874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121131

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: 2015-09-24

On-Brand Devices [BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 1]

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• 07630031707246: Bone Level Implant D 4.8mm RC, SLActive® 8mm, Roxolid® Loxim™
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• 07630031706881: Bone Level Implant, D 4.1mm RC SLActive® 12mm, Roxolid®, guided
• 07630031706874: Bone Level Implant D 4.1mm RC, SLActive® 12mm, Roxolid® Loxim™
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• 07630031706836: Bone Level Implant D 4.1mm RC, SLActive® 8mm, Roxolid® Loxim™