Identity
- Trade Name
- Durashield® CV FDA UDI
- Generic Name
- Dental cavity varnish FDA UDI
- Device Name
- Durashield® CV 5% Sodium Fluoride Clear Varnish Watermelon 50 Count of 0.40mL FDA UDI
- Model / Reference
- 0031103FG FDA UDI
- Description
- Durashield® CV 5% Sodium Fluoride Clear Varnish Watermelon 50 Count of 0.40mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- D6870031103FG1 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
Yes
FDA UDI
Over-the-Counter
No
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
Dimensions & Sizes
- Size
- Total Volume — 0.4 Milliliter FDA UDI
Category: Dental cavity varnish
Durashield® CV by Sultan Healthcare Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cavity varnish.
- NUPRO® — Dentsply Professional · Class II
- Fluorodose — CENTRIX, INC. · Class II
- NUPRO® — Dentsply Professional · Class II
- NUPRO® — Dentsply Professional · Class II
- SciPharm Copal Cavity Varnish — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- SciPharm Fluoroseal Cavity Liner — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- Hydroxyline — Taub Products · Class II
- NUPRO® — Dentsply Professional · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sultan Healthcare Inc
Sources (1)
- FDA UDI c0441960-7785-4080-9c6b-c83e0ca516b2 36 fields · synced Jun 1, 2026