ITI DISTANCE SYSTEM 048.432

GUDID 07630031724588

Bone Graft Retentive anchor, height 3.9 mm, titanium

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031724588
• NIH Device Record Key: 52bcc064-8755-4fbb-8eed-e1b4b83bb34c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ITI DISTANCE SYSTEM
• Version Model Number: Edentulous Abutments
• Catalog Number: 048.432
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031724588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931993

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[07630031724588]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-09-24

Devices Manufactured by Institut Straumann AG

• 07630031772558 - NA: 2025-04-03 Pilot Twist Drill PRO, Ø 2.2mm, short, L 34mm, stainless steel
• 07630031772565 - NA: 2025-04-03 Pilot Twist Drill PRO, Ø 2.2mm, medium, L 38mm, stainless steel
• 07630031772572 - NA: 2025-04-03 Pilot Twist Drill PRO, Ø 2.2mm, long, L 42mm, stainless steel
• 07630031772589 - NA: 2025-04-03 Twist Drill PRO, Ø 2.8mm, short, L 34mm, stainless steel
• 07630031772596 - NA: 2025-04-03 Twist Drill PRO, Ø 2.8mm, medium, L 38mm, stainless steel
• 07630031772602 - NA: 2025-04-03 Twist Drill PRO, Ø 2.8mm, long, L 42mm, stainless steel
• 07630031772619 - NA: 2025-04-03 Twist Drill PRO, Ø 3.5mm, short, L 34mm, stainless steel
• 07630031772626 - NA: 2025-04-03 Twist Drill PRO, Ø 3.5mm, medium, L 38mm, stainless steel