Monet Curing Laser

Basic Information

• Brand Name: Monet Curing Laser
• Primary DI: 00872320005610
• Version / Model: 001-00105
• Company Name: CAO GROUP, INC.
• Labeler DUNS: 102422578
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-14
• Public Version: 1
• Public Version Date: 2020-12-22
• Public Version Status: New
• Public Device Record Key: deb29eec-ff48-4722-a2b8-a219f3c1a183

Device Description

Handheld laser device used for polymerizing dental materials.

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
QNF	Laser Activator For Polymerization	Dental	872.6070	2

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	00872320005610	GS1

Customer Contacts

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