FDA UDI
In Commercial Distribution
🇺🇸 United States
Toms Sensitive + Whitening Fluoride-Free Toothpaste
DI: 00035000992970
·
Model: 61016024
·
TOM'S OF MAINE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Toms Sensitive + Whitening Fluoride-Free Toothpaste
- Primary DI
- 00035000992970
- Version / Model
- 61016024
- Company Name
- TOM'S OF MAINE, INC.
- Labeler DUNS
- 829517189
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-02
- Public Version
- 1
- Public Version Date
- 2023-06-12
- Public Version Status
- New
- Public Device Record Key
- 0a109444-fb08-4e50-996a-cf6eab93a074
Device Description
Get sensitivity relief + whitening all in one mint toothpaste for your oral care routine. The amino acid arginine + calcium carbonate complex contains arginine to deliver sensitivity relief within 60 seconds.This natural formula provides 24/7 protection for sensitive teeth and safely whitens your teeth.
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
- 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 | 10035000992977 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00035000992970 | GS1 |
Customer Contacts
- Phone
- 1-800-367-8667
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No specific requirements