FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Colgate Profesional Sensitivity Relief Serum Tube
DI: 00035000977786
·
Model: US06793A
·
COLGATE ORAL PHARMACEUTICALS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Colgate Profesional Sensitivity Relief Serum Tube
- Primary DI
- 00035000977786
- Version / Model
- US06793A
- Company Name
- COLGATE ORAL PHARMACEUTICALS, INC.
- Labeler DUNS
- 968801118
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-18
- Public Version
- 3
- Public Version Date
- 2023-08-17
- Public Version Status
- Update
- Public Device Record Key
- d4d486ac-5d8d-4baf-8c3c-aa271eb84eaf
- Distribution End Date
- 2022-11-18
Device Description
Colgate Profesional Sensitivity Relief Serum is designed to provide rapid sensitivity relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. The product is directly applied to any sensitive teeth with the fingertip and gently massaged for 1 minute. Pea-sized amount should be used on each direct application and repeated as needed on daily basis
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| LBH | Varnish, Cavity | Dental | 872.3260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35698 | Dental cavity varnish | A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00035000983749 | GS1 | Carton | 10 | Not in Commercial Distribution | 2022-11-18 |
| Primary | 00035000977786 | GS1 |
Customer Contacts
- Phone
- 7328787396
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place.