Straumann® PUREloc Abutments 032.091

GUDID 07630031735737

CI RD Straumann® PUREloc, straight 0°, H 3mm, ZrO2/Ti

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031735737
• NIH Device Record Key: 3bc53812-5d8a-4bf8-9808-6d85ae685653
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straumann® PUREloc Abutments
• Version Model Number: Edentulous Abutments
• Catalog Number: 032.091
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)448-8168
• Email: info.usa@straumann.com

Device Dimensions

• Height: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031735737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192029

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031735737]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-03
• Device Publish Date: 2020-01-25

On-Brand Devices [Straumann® PUREloc Abutments]

• 07630031735768: CI RD Straumann® PUREloc, straight 0°, H 6mm, ZrO2/Ti
• 07630031735751: CI RD Straumann® PUREloc, straight 0°, H 5mm, ZrO2/Ti
• 07630031735744: CI RD Straumann® PUREloc, straight 0°, H 4mm, ZrO2/Ti
• 07630031735737: CI RD Straumann® PUREloc, straight 0°, H 3mm, ZrO2/Ti
• 07630031735720: CI RD Straumann® PUREloc, straight 0°, H 2mm, ZrO2/Ti
• 07630031735713: CI RD Straumann® PUREloc, straight 0°, H 1mm, ZrO2/Ti