NobelProcera®

Basic Information

• Brand Name: NobelProcera®
• Primary DI: 07332747119282
• Version / Model: 30-4009-15
• Catalog Number: 30-4009-15
• Company Name: Nobel Biocare AB
• Labeler DUNS: 353939929
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 7
• Public Version Date: 2021-04-26
• Public Version Status: Update
• Public Device Record Key: 15d46583-00bf-419d-ad9e-011a56da9cf8
• Distribution End Date: 2020-11-16

Device Description

Procera® Bridge Zirconia 10 unit Intense

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELL	TEETH, PORCELAIN	Dental	872.3920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38615	Dental bridge, ceramic	A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of ceramic/porcelain material and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332747119282	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K071182	000