STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL 033.418S

GUDID 07630031715531

Standard Plus Implant, D 3.3mm NNC, SLActive® 12mm, Roxolid®

Institut Straumann AG

Screw endosteal dental implant, two-piece

• Primary Device ID: 07630031715531
• NIH Device Record Key: a27a99dc-cd31-4c5b-81c6-018baabc33a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL
• Version Model Number: 1
• Catalog Number: 033.418S
• 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: 3.3 Millimeter
• Length: 12 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	07630031715531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111357

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 NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL]

• 07630031724809: NNC Post for temporary restoration, bridge, H 10.3mm, TAN
• 07630031724793: NNC Post for temporary restoration, crown, H 10.3mm, TAN
• 07630031715548: Standard Plus Implant, D 3.3mm NNC, SLActive® 14mm, Roxolid®
• 07630031715531: Standard Plus Implant, D 3.3mm NNC, SLActive® 12mm, Roxolid®
• 07630031715524: Standard Plus Implant, D 3.3mm NNC, SLActive® 10mm, Roxolid®
• 07630031715517: Standard Plus Implant, D 3.3mm NNC, SLActive® 8mm, Roxolid®