SmileSet Premium Whitening Sample Pen – 3 ml

Basic Information

• Brand Name: SmileSet Premium Whitening Sample Pen – 3 ml
• Primary DI: 00850078989161
• Version / Model: 150-0123
• 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: 2
• Public Version Date: 2025-11-20
• Public Version Status: Update
• Public Device Record Key: c57dc70c-01f3-4f57-8eb8-962517403631

Device Characteristics

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

GMDN Terms

Code	Name	Definition	Implantable	Status
38785	Dental bleaching agent	A dental liquid solution, paste or gel [e.g., containing hydrogen peroxide (H2O2)] intended to be used chairside by a healthcare professional to whiten teeth for therapeutic (e.g., restoration of traumatised tooth colour) or cosmetic purposes. It may be supplied as a prefilled applicator or mixing syringe; some types may include a desensitising agent (e.g., potassium nitrate). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850078989161	GS1

Customer Contacts

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