FDA UDI
In Commercial Distribution
🇺🇸 United States
Colgate Optic White Professional Take-Home Whitening Kit
DI: 00035000990754
·
Model: 61012561
·
COLGATE ORAL PHARMACEUTICALS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Colgate Optic White Professional Take-Home Whitening Kit
- Primary DI
- 00035000990754
- Version / Model
- 61012561
- Company Name
- COLGATE ORAL PHARMACEUTICALS, INC.
- Labeler DUNS
- 968801118
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-08
- Public Version
- 1
- Public Version Date
- 2023-06-16
- Public Version Status
- New
- Public Device Record Key
- 9aacd2c5-07fd-433c-a27f-111126e200fd
Device Description
Colgate® Optic White® Professional features a synergistic combination of a quick-dry whitening serum and a rechargeable LED whitening device. The patented formula is designed for no tooth sensitivity, no gum irritation, and no mess. The patented LED device accelerates whitening with a short 10-minute wear time.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10035000990751 | GS1 | Case | 4 | In Commercial Distribution | |
| Primary | 00035000990754 | GS1 |
Customer Contacts
- Phone
- 1-800-226-5428
- [email protected]