33443

GUDID 07332747003314

Healing Abutment Bmk Syst NP Ø4.5x3mm

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07332747003314
• NIH Device Record Key: 22bad533-f020-4e82-8d77-45c0974d6d07
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 33443
• Catalog Number: 33443
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Device Dimensions

• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter
• Height: 3 Millimeter
• Outer Diameter: 4.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747003314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925779

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-09-17

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• 07332747207958 - NobelReplace®: 2025-07-31 NOBELREPLACE® Manual Torque Wrench Adapter Surgical
• 07332747208085 - NA: 2025-07-31 Screwdriver Manual Ball Abutment 22 mm
• 07332747208092 - NA: 2025-07-31 Screwdriver Machine Ball Abutment 24 mm
• 07332747208290 - NA: 2025-07-31 Connection to Handpiece
• 07332747208306 - NA: 2025-07-31 Impression Coping Open Tray Multi-unit
• 07332747208313 - Brånemark System®: 2025-07-31 Impression Coping Open Tray Multi-u Brånemark System® WP