SmileSet Premium Whitening Kit – Mint

Basic Information

• Brand Name: SmileSet Premium Whitening Kit – Mint
• Primary DI: 00850078989130
• Version / Model: 150-0120
• Company Name: Ortho Dental Lab LLC
• Labeler DUNS: 119338749
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-25
• Public Version: 1
• Public Version Date: 2025-10-03
• Public Version Status: New
• Public Device Record Key: e62d4919-fb05-40b9-8ebe-47d84fba0008

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: No
• 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
MAU	Eraser, Dental Stain	Dental	872.6855	1
EEG	Heat Source For Bleaching Teeth	Dental	872.6475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31806	Tooth-bleaching acceleration unit	A heat and/or light source intended to increase the oxidative effect of tooth bleachers (e.g., oxygen peroxide, carbamide peroxide, hydrogen peroxide) during tooth whitening dental procedures. It typically consists of a dedicated electromagnetic energy source (e.g., xenon lamp, LED), which may operate within a specific wavelength range, a laser, or an electric powered heater. The device is typically used during procedures in dental offices.	No	Active
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	00850078989130	GS1

Customer Contacts

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