300101

GUDID 07332747124453

Twist Step Drill Trefoil™ 4.2/4.6 11.5-13mm

Nobel Biocare AB

Fixture/appliance dental drill bit, single-use

• Primary Device ID: 07332747124453
• NIH Device Record Key: e44b5b10-24a1-4735-9d19-f08a9f14e322
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 300101
• Catalog Number: 300101
• 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

Device Dimensions

• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter
• Outer Diameter: 4.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747124453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170135

FDA Product Code

• DZI: DRILL, BONE, POWERED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-31
• Device Publish Date: 2017-06-01

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