Identity
- Trade Name
- Fluorilaq Salted Caramel (10mL) Tube FDA UDI
- Generic Name
- Dental cavity varnish FDA UDI
- Device Name
- 5% Sodium Fluoride with Xylitol. No separation, no mixing & no mess. Ideal for hypersensitivity treatments. FDA UDI
- Model / Reference
- 10402 FDA UDI
- Description
- 5% Sodium Fluoride with Xylitol. No separation, no mixing & no mess. Ideal for hypersensitivity treatments. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00310866002651 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
No
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
Yes
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
Fluorilaq Salted Caramel (10mL) Tube by Pascal Company, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental cavity varnish.
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- 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 |
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Manufacturer
- Manufacturer
- Pascal Company, Inc.
Sources (1)
- FDA UDI 60b73d7e-df65-40a2-8833-5a5ac0520184 34 fields · synced Jun 8, 2026