300167

GUDID 17332747009528

Healing Cap Wide Multi-unit Titanium Ø5.0x5.5mm 2/pkg

Nobel Biocare AB

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 17332747009528
• NIH Device Record Key: 6911a1af-a7a7-417a-a4fb-29105481e75d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 300167
• Catalog Number: 300167
• 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: 6.9 Millimeter
• Outer Diameter: 6.9 Millimeter
• Outer Diameter: 6.9 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter
• Height: 5.5 Millimeter
• Outer Diameter: 6.9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747156508 [Unit of Use]
GS1	17332747009528 [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: 2017-12-01

Devices Manufactured by Nobel Biocare AB

• 07332747215052 - Nobel Biocare®: 2024-06-28 Nobel Biocare Multi-unit PoLo 8mm
• 07332747215069 - Nobel Biocare®: 2024-06-28 Nobel Biocare Multi-unit PoLo Bmk WP 8mm
• 07332747215076 - Nobel Biocare®: 2024-06-28 Nobel Biocare Multi-unit PoLo Link 10mm
• 07332747215083 - Nobel Biocare®: 2024-06-28 Nobel Biocare Multi-unit PoLo Link 15mm
• 07332747215090 - Nobel Biocare®: 2024-06-28 Nobel Biocare Multi-unit PoLo Link 20mm
• 07332747215106 - Nobel Biocare®: 2024-06-28 Nobel Biocare ReverseScan Multi-unit
• 07332747215113 - Nobel Biocare®: 2024-06-28 Nobel Biocare ReverseScan Multi-unit Bmk WP
• 07332747218008 - Nobel Biocare®: 2024-06-28 Nobel Biocare Multi-unit PoLo Prosthetic Screw 5/pkg