STRAUMANN EXTRAORAL IMPLANT SYSTEM 048.044

GUDID 07630031722409

EO Healing cap, D 3.5mm, L 3.8mm, Ti

Institut Straumann AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07630031722409
• NIH Device Record Key: 4163d991-c642-4f24-b9dd-700f05d01600
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRAUMANN EXTRAORAL IMPLANT SYSTEM
• Version Model Number: EO
• Catalog Number: 048.044
• 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: false
• 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: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031722409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990458

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07630031722409]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-04
• Device Publish Date: 2015-09-24

On-Brand Devices [STRAUMANN EXTRAORAL IMPLANT SYSTEM]

• 07630031722409: EO Healing cap, D 3.5mm, L 3.8mm, Ti
• 07630031724878: EO Paralleling guide, Ø 3.5mm, L 15.0mm, stainless steel
• 07630031724830: EO conical abutment 15° short, Neck lenght 5.5 mm, Titanium
• 07630031724823: EO conical abutment 15° short, Neck lenght 3.5 mm, Titanium
• 07630031723703: EO Gold cap 15°, Ø 4.8mm, L 5.5mm, ceramicon
• 07630031721433: EO implant iserting device, Length 10.0 mm, Stainless steel, PEEK
• 07630031720016: EO Stop drill for implant 042.362S Ø 2.8mm, L 24mm, stainless steel
• 07630031720009: EO Stop drill for implant 042.360S Ø 2.8mm, L 22.5mm, stainless steel
• 07630031719997: EO Profile drill for implant 042.367S Ø 2.8mm, L 25mm, stainless steel
• 07630031719980: EO Profile drill for implant 042.365S Ø 2.8mm, L 25mm, stainless steel
• 07630031718211: EO implant Ø 3.3 / 5.5 mm, Insertion depth 4.0 mm, Titanium
• 07630031718204: EO implant Ø 3.3 / 5.5 mm, Insertion depth 2.5 mm, Titanium
• 07630031718198: EO implant Ø 3.3 / 3.5 mm, Insertion depth 5.0 mm, Titanium
• 07630031718181: EO implant Ø 3.3 / 3.5 mm, Insertion depth 3.5 mm, Titanium