301123

GUDID 07332747166835

On1 Universal Abutment Engaging RP 0.3 mm US

Nobel Biocare AB

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
• 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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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

[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

Devices Manufactured by Nobel Biocare AB

• 07332747224665 - NA: 2025-05-27 Temporary Prosthetic Screw Multi-unit Abutment
• 07332747207828 - Nobel Biocare®: 2025-05-26 Abutment Screw TorqTite 3.8/4.3/4.5/5.0/6.0 HL/RPL
• 07332747207835 - NA: 2025-05-26 Implant Analog 5.0 HL/RPL
• 07332747207880 - NA: 2025-05-26 Implant Analog 6.0 HL/RPL
• 07332747150384 - Nobel Biocare®: 2025-05-26 Prosthetic screw UniGrip™ Novum 2-pack
• 07332747150391 - Nobel Biocare®: 2025-05-26 Lower bar screw UniGrip™ Novum 3-pack
• 07332747207910 - NA: 2025-05-26 Replica Fixture Novum
• 07332747207927 - Brånemark System®: 2025-05-26 Screw Ceramic Abutment Bmk Syst RP