Straumann® Dental Implant System Roxolid® SLA Impl. 021.5508

GUDID 07630031707123

Bone Level Tapered Implant, D 4.1mm RC, SLA® 8mm, Roxolid®, Loxim™

Institut Straumann AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07630031707123
• NIH Device Record Key: e336918f-8bf0-4373-bb6b-df6ac39e0205
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann® Dental Implant System Roxolid® SLA Impl.
• Version Model Number: SLA Roxolid BL
• Catalog Number: 021.5508
• 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

• Outer Diameter: 4.1 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	07630031707123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150938

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: 4
• Public Version Date: 2019-04-04
• Device Publish Date: 2015-09-24

On-Brand Devices [Straumann® Dental Implant System Roxolid® SLA Impl.]

• 07630031719058: Standard Plus Implant, D 3.3mm NNC, SLA® 8mm, Roxolid®, Loxim™
• 07630031719034: Tapered Effect Implant, D 3.3mm RN, SLA® 12mm, Roxolid®,Loxim™
• 07630031719010: Tapered Effect Implant, D 3.3mm RN, SLA® 8mm, Roxolid®, Loxim™
• 07630031718983: Standard Plus Implant, D 3.3mm RN, SLA® 10mm, Roxolid®, Loxim™
• 07630031718952: Standard Implant, D 3.3mm RN, SLA® 14mm, Roxolid®, Loxim™
• 07630031718945: Standard Implant, D 3.3mm RN, SLA® 12mm, Roxolid®, Loxim™
• 07630031718938: Standard Implant, D 3.3mm RN, SLA® 10mm, Roxolid®, Loxim™
• 07630031718815: Tapered Effect Implant, D 4.1mm RN, SLA® 14mm, Roxolid®, Loxim™
• 07630031718808: Tapered Effect Implant, D 4.1mm RN, SLA® 12mm, Roxolid®, Loxim™
• 07630031718792: Tapered Effect Implant, D 4.1mm RN, SLA® 10mm, Roxolid®, Loxim™
• 07630031718785: Tapered Effect Implant, D 4.1mm RN, SLA® 8mm, Roxolid®, Loxim™
• 07630031718778: Standard Plus Implant, D 4.1mm RN, SLA® 14mm, Roxolid®, Loxim™
• 07630031718761: Standard Plus Implant, D 4.1mm RN, SLA® 12mm, Roxolid®, Loxim™
• 07630031718754: Standard Plus Implant, D 4.1mm RN, SLA® 10mm, Roxolid®, Loxim™
• 07630031718747: Standard Plus Implant, D 4.1mm RN, SLA® 8mm, Roxolid®, Loxim™
• 07630031718730: Standard Plus Implant, D 4.1mm RN, SLA® 6mm, Roxolid®, Loxim™
• 07630031718723: Standard Implant, D 4.1mm RN, SLA® 16mm, Roxolid®, Loxim™
• 07630031718716: Standard Implant, D 4.1mm RN, SLA® 14mm, Roxolid®, Loxim™
• 07630031718709: Standard Implant, D 4.1mm RN, SLA® 12mm, Roxolid®, Loxim™
• 07630031718693: Standard Implant, D 4.1mm RN, SLA® 10mm, Roxolid® Loxim™
• 07630031718686: Standard Implant, D 4.1mm RN, SLA® 8mm, Roxolid® Loxim™
• 07630031718570: Standard Plus Implant, D 4.8mm RN, SLA® 14mm, Roxolid®, Loxim™
• 07630031718549: Standard Plus Implant, D 4.8mm RN, SLA® 8mm, Roxolid®, Loxim™
• 07630031718488: Standard Implant, D 4.8mm RN, SLA® 6mm, Roxolid®, Loxim™
• 07630031707147: Bone Level Tapered Implant, D 4.1mm RC, SLA® 12mm, Roxolid®, Loxim™
• 07630031707123: Bone Level Tapered Implant, D 4.1mm RC, SLA® 8mm, Roxolid®, Loxim™
• 07630031706973: Bone Level Implant, D 4.1mm RC, SLA® 14mm, Roxolid®, Loxim™
• 07630031706959: Bone Level Implant, D 4.1mm RC, SLA® 10mm, Roxolid®, Loxim™
• 07630031706942: Bone Level Implant, D 4.1mm RC, SLA® 8mm, Roxolid®, Loxim™
• 07630031706560: Bone Level Implant, D 3.3mm NC, SLA® 14mm, Roxolid®, Loxim™
• 07630031706546: Bone Level Implant, D 3.3mm NC, SLA® 10mm, Roxolid®, Loxim™