Straumann® Dental Implant System Roxolid® SLA Imp 043.658S

GUDID 07630031719249

Standard Plus Implant, D 4.8mm WN, SLA® 12mm, Roxolid®, Loxim™

Institut Straumann AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07630031719249
• NIH Device Record Key: 2c985766-925e-4489-8805-f0ec6917e5fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann® Dental Implant System Roxolid® SLA Imp
• Version Model Number: 1
• Catalog Number: 043.658S
• 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: 4.8 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	07630031719249 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

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

• 07630031719287: Tapered Effect Implant, D 4.8mm WN, SLA® 14mm, Roxolid®, Loxim™
• 07630031719270: Tapered Effect Implant, D 4.8mm WN, SLA® 12mm, Roxolid®, Loxim™
• 07630031719263: Tapered Effect Implant, D 4.8mm WN, SLA® 10mm, Roxolid®, Loxim™
• 07630031719249: Standard Plus Implant, D 4.8mm WN, SLA® 12mm, Roxolid®, Loxim™
• 07630031719232: Standard Plus Implant, D 4.8mm WN, SLA® 10mm, Roxolid®, Loxim™
• 07630031719225: Standard Plus Implant, D 4.8mm WN, SLA® 8mm, Roxolid®, Loxim™
• 07630031719218: Standard Plus Implant, D 4.8mm WN, SLA® 6mm, Roxolid®, Loxim™
• 07630031719126: Standard Implant, D 4.8mm WN, SLA® 12mm, Roxolid®, Loxim™
• 07630031719119: Standard Implant, D 4.8mm WN, SLA® 10mm, Roxolid®, Loxim™
• 07630031719102: Standard Implant, D 4.8mm WN, SLA® 8mm, Roxolid®, Loxim™
• 07630031719096: Standard Implant, D 4.8mm WN, SLA® 6mm, Roxolid®, Loxim™
• 07630031719089: Standard Plus Implant, D 3.3mm NNC, SLA® 14mm, Roxolid®, Loxim™
• 07630031719072: Standard Plus Implant, D 3.3mm NNC, SLA® 12mm, Roxolid®, Loxim™
• 07630031719065: Standard Plus Implant, D 3.3mm NNC, SLA® 10mm, Roxolid®, Loxim™
• 07630031719041: Tapered Effect Implant, D 3.3mm RN, SLA® 14mm, Roxolid®, Loxim™
• 07630031719027: Tapered Effect Implant, D 3.3mm RN, SLA® 10mm, Roxolid®, Loxim™
• 07630031719003: Standard Plus Implant, D 3.3mm RN, SLA® 14mm, Roxolid®, Loxim™
• 07630031718990: Standard Plus Implant, D 3.3mm RN, SLA® 12mm, Roxolid®, Loxim™
• 07630031718976: Standard Plus Implant, D 3.3mm RN, SLA® 8mm, Roxolid®, Loxim™
• 07630031718969: Standard Implant, D 3.3mm RN, SLA® 16mm, Roxolid®, Loxim™
• 07630031718921: Standard Implant, D 3.3mm RN, SLA® 8mm, Roxolid®, Loxim™
• 07630031718679: Standard Implant, D 4.1mm RN, SLA® 6mm, Roxolid® Loxim™
• 07630031718563: Standard Plus Implant, D 4.8mm RN, SLA® 12mm, Roxolid®, Loxim™
• 07630031718556: Standard Plus Implant, D 4.8mm RN, SLA® 10mm, Roxolid®, Loxim™
• 07630031718532: Standard Plus Implant, D 4.8mm RN, SLA® 6mm, Roxolid®, Loxim™
• 07630031718525: Standard Implant, D 4.8mm RN, SLA® 14mm, Roxolid®, Loxim™
• 07630031718518: Standard Implant, D 4.8mm RN, SLA® 12mm, Roxolid®, Loxim™
• 07630031718501: Standard Implant, D 4.8mm RN, SLA® 10mm, Roxolid®, Loxim™
• 07630031718495: Standard Implant, D 4.8mm RN, SLA® 8mm, Roxolid®, Loxim™
• 07630031707574: Bone Level Tapered Implant, D 4.8mm RC, SLA® 16mm, Roxolid®, Loxim™
• 07630031707567: Bone Level Tapered Implant, D 4.8mm RC, SLA® 14mm, Roxolid®, Loxim™
• 07630031707550: Bone Level Tapered Implant, D 4.8mm RC, SLA® 12mm, Roxolid®, Loxim™
• 07630031707543: Bone Level Tapered Implant, D 4.8mm RC, SLA® 10mm, Roxolid®, Loxim™
• 07630031707536: Bone Level Tapered Implant, D 4.8mm RC, SLA® 8mm, Roxolid®, Loxim™
• 07630031707383: Bone Level Implant, D 4.8mm RC, SLA® 14mm, Roxolid®, Loxim™
• 07630031707376: Bone Level Implant, D 4.8mm RC, SLA® 12mm, Roxolid®, Loxim™
• 07630031707369: Bone Level Implant, D 4.8mm RC, SLA® 10mm, Roxolid®, Loxim™
• 07630031707352: Bone Level Implant, D 4.8mm RC, SLA® 8mm, Roxolid®, Loxim™
• 07630031707161: Bone Level Tapered Implant, D 4.1mm RC, SLA® 16mm, Roxolid®, Loxim™
• 07630031707154: Bone Level Tapered Implant, D 4.1mm RC, SLA® 14mm, Roxolid®, Loxim™
• 07630031707130: Bone Level Tapered Implant, D 4.1mm RC, SLA® 10mm, Roxolid®, Loxim™
• 07630031706966: Bone Level Implant, D 4.1mm RC, SLA® 12mm, Roxolid®, Loxim™
• 07630031706751: Bone Level Tapered Implant, D 3.3mm NC, SLA® 16mm, Roxolid®, Loxim™
• 07630031706744: Bone Level Tapered Implant, D 3.3mm NC, SLA® 14mm, Roxolid®, Loxim™
• 07630031706737: Bone Level Tapered Implant, D 3.3mm NC, SLA® 12mm, Roxolid®, Loxim™
• 07630031706720: Bone Level Tapered Implant, D 3.3mm NC, SLA® 10mm, Roxolid®, Loxim™
• 07630031706713: Bone Level Tapered Implant, D 3.3mm NC, SLA® 8mm, Roxolid®, Loxim™
• 07630031706553: Bone Level Implant, D 3.3mm NC, SLA® 12mm, Roxolid®, Loxim™
• 07630031706539: Bone Level Implant, D 3.3mm NC, SLA® 8mm, Roxolid®, Loxim™