Individo Lux

Basic Information

• Brand Name: Individo Lux
• Primary DI: E22122011
• Version / Model: 2201
• Catalog Number: 2201
• 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: 41f2cd00-0b23-44d8-8ae1-47c219491afb

Device Description

lndivido Lux blue opaque and lndivido Lux transparent blue are opaque respectively transparent light-curing resins in form of contoured plates for maxillae and mandibles for the fabrication of individual trays for use in crown, bridge and total prosthetic technique as well as for the fabrication of bases for bite patterns and odontograms. They are ready for use and easy to handle without any odor nuisance.

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	E22122011	HIBCC
Unit of Use	E2212201	HIBCC

Customer Contacts

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