Identity
- Trade Name
- Durashield® FDA UDI
- Generic Name
- Dental cavity varnish FDA UDI
- Device Name
- Durashield® 5% Sodium Fluoride Varnish, Bubble Fun® 200 units of 0.40mL FDA UDI
- Model / Reference
- AD31102 FDA UDI
- Description
- Durashield® 5% Sodium Fluoride Varnish, Bubble Fun® 200 units of 0.40mL FDA UDI
Identifiers
- Primary DI / UDI-DI
- D687AD311021 FDA UDI
- 510(k) Number
- K982915 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
- Not 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
Durashield® by Sultan Healthcare Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Sultan Healthcare Inc
Sources (1)
- FDA UDI 0401e008-e13a-4e44-8e3b-385d3cbbfd52 38 fields · synced May 29, 2026