Nobel Biocare®

Basic Information

• Brand Name: Nobel Biocare®
• Primary DI: 17332747007104
• Version / Model: 37895
• Catalog Number: 37895
• Company Name: Nobel Biocare AB
• Labeler DUNS: 353939929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-09-10
• Public Version: 2
• Public Version Date: 2020-12-14
• Public Version Status: Update
• Public Device Record Key: 08fb7e6a-80f9-43b8-8e15-31f1818a45e5

Device Description

Lab Screw Implant Level CC RP/WP and Ext Hex RP 5/pkg

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, implant, dental, endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46122	Dental implant suprastructure, temporary, preformed, reusable	A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17332747007104	GS1
Unit of Use	07332747150292	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]