WR Premium Perfection Kit Led EU

Basic Information

• Brand Name: WR Premium Perfection Kit Led EU
• Primary DI: E241WR0100
• Version / Model: WR010
• Catalog Number: WR010
• Company Name: Cavex Holland B.V.
• Labeler DUNS: 419980156
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-09
• Public Version: 1
• Public Version Date: 2026-03-17
• Public Version Status: New
• Public Device Record Key: 8e93742d-02a2-4d3e-82c6-a4f6c9510ac2

Device Description

Dental Whitening Agent

Device Characteristics

• Single Use: No
• 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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
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	E241WR0100	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 pcs

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 10 Degrees Celsius