301125

GUDID 07332747166859

On1 Universal Abutment Engaging WP 0.3 mm US

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07332747166859
• NIH Device Record Key: c07d21ab-086f-4673-8671-a034bcd8691c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 301125
• Catalog Number: 301125
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• 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)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com

Device Dimensions

• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter
• Height: 0.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747166859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181869

FDA Product Code

• PNP: Dental abutment design software for dental laboratory

Sterilization

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

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

[07332747166859]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-01-28

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