ORTOLUX TOP

Basic Information

• Brand Name: ORTOLUX TOP
• Primary DI: 08435288434926
• Version / Model: POSTERIOR TEETH A3/52S
• Catalog Number: M3A352S
• Company Name: UNION DENTAL SA
• Labeler DUNS: 462114760
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-20
• Public Version: 1
• Public Version Date: 2024-09-30
• Public Version Status: New
• Public Device Record Key: d30511f1-654e-4423-96f5-3239ccfc4f45

Device Description

ORTOLUX TOP posterior Teeth Shade A3, Mould 52 up.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
ELM	Denture, Plastic, Teeth	Dental	872.3590	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38643	Resin artificial teeth	Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08435288434926	GS1

Premarket Submissions

Submission Number	Supplement Number
K070591	000