STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY CO 027.4318

GUDID 07630031713698

RC Cementable All-In-One Set, for crown, D 5mm, AH 5.5mm, GH 3mm

Institut Straumann AG

Dental implant suprastructure kit

• Primary Device ID: 07630031713698
• NIH Device Record Key: cdd4bfa8-5023-48e9-9d2b-b16434be399d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY CO
• Version Model Number: 1
• Catalog Number: 027.4318
• 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: 5 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031713698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072071

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031713698]

Moist Heat or Steam Sterilization

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 P.004 CEMENTABLE ABUTMENTS, TEMPORARY CO]

• 07630031713759: RC Cementable All-In-One Set, for crown, D 6.5mm, AH 5.5mm, GH 3mm
• 07630031713735: RC Cementable All-In-One Set, for crown, D 6.5mm, AH 5.5mm, GH 1mm
• 07630031713728: RC Cementable All-In-One Set, for crown, D 6.5mm, AH 4mm, GH 3mm
• 07630031713698: RC Cementable All-In-One Set, for crown, D 5mm, AH 5.5mm, GH 3mm
• 07630031713681: RC Cementable All-In-One Set, for crown, D 5mm, AH 5.5mm, GH 2mm
• 07630031713643: RC Cementable All-In-One Set, for crown, D 5mm, AH 4mm, GH 1mm
• 07630031710840: RC Temporary Coping, for Cementable Abutment, D 5mm, PMMA
• 07630031710819: RC Protective Cap, for Cementable Abutment, D 6.5mm, AH 5.5mm, PEEK
• 07630031709677: RC Coping, for crown on Cementable Abutment, D 6.5mm, POM
• 07630031709660: RC Coping, for bridge on Cementable Abutment, D 6.5mm, POM
• 07630031709653: RC Coping, for crown on Cementable Abutment, D 5mm, POM
• 07630031709646: RC Coping, for bridge on Cementable Abutment, D 5mm, POM