301123

GUDID 07332747166835

On1 Universal Abutment Engaging RP 0.3 mm US

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07332747166835
• NIH Device Record Key: 8541e057-096e-4b9d-9f2b-8cee12c00b41
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 301123
• Catalog Number: 301123
• 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
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• 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	07332747166835 [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

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

Moist Heat or Steam Sterilization

[07332747166835]

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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