APOZA

Basic Information

• Brand Name: APOZA
• Primary DI: 04719883751355
• Version / Model: LIGHT GUIDE-13mm
• Company Name: APOZA ENTERPRISE CO., LTD.
• Labeler DUNS: 656816337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-21
• Public Version: 1
• Public Version Date: 2023-06-29
• Public Version Status: New
• Public Device Record Key: 70f6d4f7-069d-4fed-aaf3-0c69cf91f26a

Device Description

Light Guide 13mm. Accessories for APOZA LED Light Curing Unit

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: 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
EAY	Light, Fiber Optic, Dental	Dental	872.4620	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35775	Dental/surgical polymerization lamp	A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719883751355	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			13 Millimeter Tip Diameter