MODIFICATION TO ITI DENTAL IMPLANT SYSTEM 043.926S

GUDID 07630031719607

Standard Plus Implant, D 4.1mm RN, SLA® 8mm, Ti, Loxim™

Institut Straumann AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07630031719607
• NIH Device Record Key: c07f0a88-6b36-4632-85ab-befccf99cd25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
• Version Model Number: 1
• Catalog Number: 043.926S
• 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: 8 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	07630031719607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033922

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 [MODIFICATION TO ITI DENTAL IMPLANT SYSTEM]

• 07630031719850: Standard Plus Implant, D 4.8mm WN, SLA® 12mm, Ti, Loxim™
• 07630031719843: Standard Plus Implant, D 4.8mm WN, SLA® 10mm, Ti, Loxim™
• 07630031719836: Standard Plus Implant, D 4.8mm WN, SLA® 8mm, Ti, Loxim™
• 07630031719829: Standard Plus Implant, D 4.8mm WN, SLA® 6mm, Ti, Loxim™
• 07630031719782: Standard Implant, D 4.8mm WN, SLA® 6mm, Ti, Loxim™
• 07630031719775: Standard Plus Implant, D 4.8mm RN, SLA® 14mm, Ti, Loxim™
• 07630031719768: Standard Plus Implant, D 4.8mm RN, SLA® 12mm, Ti, Loxim™
• 07630031719751: Standard Plus Implant, D 4.8mm RN, SLA® 10mm, Ti, Loxim™
• 07630031719744: Standard Plus Implant, D 4.8mm RN, SLA® 8mm, Ti, Loxim™
• 07630031719737: Standard Plus Implant, D 4.8mm RN, SLA® 6mm, Ti, Loxim™
• 07630031719683: Standard Implant, D 4.8mm RN, SLA® 6mm, Ti, Loxim™
• 07630031719638: Standard Plus Implant, D 4.1mm RN, SLA® 14mm, Ti, Loxim™
• 07630031719621: Standard Plus Implant, D 4.1mm RN, SLA® 12mm, Ti, Loxim™
• 07630031719614: Standard Plus Implant, D 4.1mm RN, SLA® 10mm, Ti, Loxim™
• 07630031719607: Standard Plus Implant, D 4.1mm RN, SLA® 8mm, Ti, Loxim™
• 07630031719591: Standard Plus Implant, D 4.1mm RN, SLA® 6mm, Ti, Loxim™
• 07630031719539: Standard Implant, D 4.1mm RN, SLA® 6mm, Ti, Loxim™
• 07630031719485: Standard Plus Implant, D 3.3mm RN, SLA® 14mm, Ti, Loxim™
• 07630031719478: Standard Plus Implant, D 3.3mm RN, SLA® 12mm, Ti, Loxim™
• 07630031719461: Standard Plus Implant, D 3.3mm RN, SLA® 10mm, Ti, Loxim™
• 07630031719454: Standard Plus Implant, D 3.3mm RN, SLA® 8mm, Ti, Loxim™
• 07630031719201: Standard Plus Implant, D 4.8mm, WN, SLA 12mm, Ti
• 07630031719195: Standard Plus Implant, D 4.8mm, WN, SLA 10mm, Ti
• 07630031719188: Standard Plus Implant, D 4.8mm, WN, SLA 8mm, Ti
• 07630031719171: Standard Plus Implant, D 4.8mm, WN, SLA 6mm, Ti
• 07630031719133: Standard Implant, D 4.8mm, WN, SLA 6mm, Ti
• 07630031718877: Standard Plus Implant, D 4.8mm, RN, SLA 6mm, Ti
• 07630031718822: Standard Implant, D 4.8mm, RN, SLA 6mm, Ti
• 07630031718372: Standard Plus Implant, D 4.1mm, RN, SLA 6mm, Ti
• 07630031718310: Standard Implant, D 4.1mm, RN, SLA 6mm, Ti
• 07630031701022: Standard Plus Implant,D 4.8mm, RN, SLA 14mm, Ti
• 07630031701015: Standard Plus Implant, D 4.8mm, RN, SLA 12mm, Ti
• 07630031701008: Standard Plus Implant, D 4.8mm, RN, SLA 10mm, Ti
• 07630031700995: Standard Plus Implant, D 4.8mm, RN, SLA 8mm, Ti
• 07630031700988: Standard Plus Implant,D 3.3mm, RN, SLA 14mm, Ti
• 07630031700971: Standard Plus Implant, D 3.3mm, RN, SLA 12mm, Ti
• 07630031700964: Standard Plus Implant, D 3.3mm, RN, SLA 10mm, Ti
• 07630031700957: Standard Plus Implant, D 3.3mm, RN, SLA 8mm, Ti
• 07630031700940: Standard Plus Implant, D 4.1mm, RN, SLA 14mm, Ti
• 07630031700933: Standard Plus Implant, D 4.1mm, RN, SLA 12mm, Ti
• 07630031700926: Standard Plus Implant, D 4.1mm, RN, SLA 10mm, Ti
• 07630031700919: Standard Plus Implant, D 4.1mm, RN, SLA 8mm, Ti