Hiflex Modelling Wax

Basic Information

• Brand Name: Hiflex Modelling Wax
• Primary DI: D967130030
• Version / Model: 24 sheets 500g
• Catalog Number: 13003
• Company Name: PREVEST DENPRO LIMITED
• Labeler DUNS: 859546940
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-19
• Public Version: 1
• Public Version Date: 2022-12-27
• Public Version Status: New
• Public Device Record Key: da9d23d2-e3a9-4fa6-9c39-e4cd8fb29439

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: Yes
• 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
EGD	Wax, Dental, Intraoral	Dental	872.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63983	Denture trial fabrication wax	A material made primarily of wax, intended to be used in the dental laboratory to manufacture a trial denture/denture base. It is not intended to be used as an anatomical impression material nor is it intended to be used to manufacture a final dental prosthesis/appliance. It is commonly supplied in sheets and may be referred to as denture sheet wax. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D967130030	HIBCC