FDA UDI
In Commercial Distribution
🇺🇸 United States
WR Premium Perfection Kit + Led
DI: E241WR0040
·
Model: BW004
·
Cavex Holland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- WR Premium Perfection Kit + Led
- Primary DI
- E241WR0040
- Version / Model
- BW004
- Catalog Number
- BW004
- 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
- 362ee96d-7bb2-4301-bf9a-195a0c10fed3
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 |
|---|---|---|---|---|---|---|
| Direct Marking | 08719327516041 | GS1 | ||||
| Primary | E241WR0040 | HIBCC |
Customer Contacts
- Phone
- +31(0)235307700
- [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