NobelZygoma™ 38289

GUDID 07332747102796

NobelZygoma™ 45° 45mm

Nobel Biocare AB

Screw endosteal dental implant, two-piece

• Primary Device ID: 07332747102796
• NIH Device Record Key: eccecdfa-ca8e-4f69-8713-a5f5faca0165
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NobelZygoma™
• Version Model Number: 38289
• Catalog Number: 38289
• 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

Device Dimensions

• Length: 45 Millimeter
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter
• Angle: 45 degree
• Length: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747102796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152093

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-31
• Device Publish Date: 2016-05-25

On-Brand Devices [NobelZygoma™]

• 07332747112405: NobelZygoma™ 0° Angled Multi-unit Abutment Screw
• 07332747102826: NobelZygoma™ 45° 52.5mm
• 07332747102819: NobelZygoma™ 45° 50mm
• 07332747102802: NobelZygoma™ 45° 47.5mm
• 07332747102796: NobelZygoma™ 45° 45mm
• 07332747102789: NobelZygoma™ 45° 42.5mm
• 07332747102772: NobelZygoma™ 45° 40mm
• 07332747102765: NobelZygoma™ 45° 37.5mm
• 07332747102758: NobelZygoma™ 45° 35mm
• 07332747102741: NobelZygoma™ 45° 32.5mm
• 07332747102734: NobelZygoma™ 45° 30mm
• 07332747102727: NobelZygoma™ 0° 50mm
• 07332747102710: NobelZygoma™ 0° 47.5mm
• 07332747102703: NobelZygoma™ 0° 45mm
• 07332747098792: NobelZygoma™ 0° 42.5mm
• 07332747098785: NobelZygoma™ 0° 40mm
• 07332747098778: NobelZygoma™ 0° 37.5mm
• 07332747098761: NobelZygoma™ 0° 35mm
• 07332747098754: NobelZygoma™ 0° 30mm
• 07332747161632: NobelZygoma™ 45° 52.5mm
• 07332747161625: NobelZygoma™ 45° 50mm
• 07332747161618: NobelZygoma™ 45° 47.5mm
• 07332747161601: NobelZygoma™ 45° 45mm
• 07332747161595: NobelZygoma™ 45° 42.5mm
• 07332747161588: NobelZygoma™ 45° 40mm
• 07332747161571: NobelZygoma™ 45° 37.5mm
• 07332747161564: NobelZygoma™ 45° 35mm
• 07332747161557: NobelZygoma™ 45° 32.5mm
• 07332747161540: NobelZygoma™ 45° 30mm
• 07332747161533: NobelZygoma™ 0° 50mm
• 07332747161526: NobelZygoma™ 0° 47.5mm
• 07332747161519: NobelZygoma™ 0° 45mm
• 07332747161502: NobelZygoma™ 0° 42.5mm
• 07332747161496: NobelZygoma™ 0° 40mm
• 07332747161489: NobelZygoma™ 0° 37.5mm
• 07332747161472: NobelZygoma™ 0° 35mm
• 07332747161465: NobelZygoma™ 0° 30mm
• 07332747089134: NobelZygoma 0° Twist Drill 4.4mm Short
• 07332747089127: NobelZygoma 0° Twist Drill 4.4mm
• 07332747089110: NobelZygoma 0° Twist Drill 4.0mm Short
• 07332747089103: NobelZygoma 0° Twist Drill 4.0mm
• 07332747089097: NobelZygoma 0° Twist Drill 3.5mm Short
• 07332747089080: NobelZygoma 0° Twist Drill 3.5mm
• 07332747089073: NobelZygoma 0° Twist Drill 2.9mm Short
• 07332747089066: NobelZygoma 0° Twist Drill 2.9mm