300162

GUDID 17332747009573

Healing Cap Multi-unit Titanium Ø5.0x4.1mm 2/pkg

Nobel Biocare AB

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 17332747009573
• NIH Device Record Key: 8f46212f-e52e-44b7-af5f-833bbf70e188
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 300162
• Catalog Number: 300162
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• Device Count: 2
• 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: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4.1 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747156454 [Unit of Use]
GS1	17332747009573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171142

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: 5
• Public Version Date: 2019-05-31
• Device Publish Date: 2017-12-04

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