Identity
- Trade Name
- SenzAway FDA UDI
- Generic Name
- Dental cavity varnish FDA UDI
- Device Name
- 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) FDA UDI
- Model / Reference
- 1 FDA UDI
- 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) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00010705400456 FDA UDI
- 510(k) Number
- K120176 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental cavity varnish FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental cavity varnish
SenzAway by Majestic Drug Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cavity varnish.
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- Hydroxyline — Taub Products · Class II
- NUPRO® — Dentsply Professional · Class II
Cleared under the same submission
K120176 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Majestic Drug Co., Inc.
Sources (1)
- FDA UDI 42c278a9-8498-4107-949f-481d0b83b841 36 fields · synced Jun 8, 2026