GlorySmile

Basic Information

• Brand Name: GlorySmile
• Primary DI: 06970016627567
• Version / Model: GS-013V
• Company Name: Nanchang Dentalbright Technology Co.,Ltd
• Labeler DUNS: 544503502
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-22
• Public Version: 2
• Public Version Date: 2023-05-08
• Public Version Status: Update
• Public Device Record Key: 7875b561-7a7c-41d8-b941-29b6d499e46b

Device Characteristics

• Single Use: No
• 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: 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
MAU	Eraser, Dental Stain	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46432	Teeth whitening kit	A collection of devices intended to whiten natural teeth through bleaching. It typically includes a bleaching agent (e.g., a gel containing a low concentration of an oxidizing agent, such as carbamide peroxide or hydrogen peroxide), a syringe(s), a tray(s), a mouthguard, an applicator (e.g., a brush) and strips to apply/retain the bleaching agent to/on the teeth for a recommended period. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970016627567	GS1