Profibase

Basic Information

• Brand Name: Profibase
• Primary DI: E22121141
• Version / Model: 2114
• Catalog Number: 2114
• Company Name: VOCO GmbH
• Labeler DUNS: 316699578
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2019-06-06
• Public Version: 1
• Public Version Date: 2019-06-14
• Public Version Status: New
• Public Device Record Key: 1485a637-6368-4ebd-b7d6-8a714e4fd57c

Device Description

Profibase is a light-curing resin in pre-contoured plates for maxillae and mandibles for the fabrication of individual impression and functional trays for use in crown, bridge and total prosthetic technique to be used for the fabrication of bases of bite patterns as well as for dimensionally stable base plates for wax contouring in the total prosthetic technique. The material is ready for use and easy to handle.

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBH	Material, Impression Tray, Resin	Dental	872.3670	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34808	Dental base plate	A foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E22121141	HIBCC
Unit of Use	E2212114	HIBCC

Customer Contacts

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