Brightbyte Pro (wireless) Whitening Kit

Basic Information

• Brand Name: Brightbyte Pro (wireless) Whitening Kit
• Primary DI: 00850017524200
• Version / Model: BYTEBBP2
• Company Name: STRAIGHT SMILE LLC
• Labeler DUNS: 081010579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-07
• Public Version: 1
• Public Version Date: 2023-09-15
• Public Version Status: New
• Public Device Record Key: 40842b99-90ae-4c5c-9468-268bcef04578

Device Description

[Wireless] LED teeth whitening kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: 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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850017524200	GS1

Customer Contacts

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