FDA UDI
In Commercial Distribution
🇺🇸 United States
SenzAway
DI: 00010705400456
·
Model: 1
·
MAJESTIC DRUG CO. INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SenzAway
- Primary DI
- 00010705400456
- Version / Model
- 1
- Company Name
- MAJESTIC DRUG CO. INC.
- Labeler DUNS
- 001496777
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 42c278a9-8498-4107-949f-481d0b83b841
Device Description
SenzAway is a gel designed to relieve sensitivity of teeth to cold, sweet and hot food and liquids. One application should relieve sensitivity of teeth immediately and will last at least three months (individual results may vary)
Device Characteristics
- Single Use
- Yes
- 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 | 50010705400451 | GS1 | Case | 16 | In Commercial Distribution | |
| Package | 70010705400455 | GS1 | Pack | 6 | In Commercial Distribution | |
| Primary | 00010705400456 | GS1 |
Customer Contacts
- Phone
- (800) 238-0220
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120176 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room temperature