Identity
- Trade Name
- Profluorid L FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing FDA UDI
- Device Name
- Fluoride varnish for the treatment of hypersensitivity FDA UDI
- Model / Reference
- 1591 FDA UDI
- Description
- Fluoride varnish for the treatment of hypersensitivity FDA UDI
Identifiers
- Catalog Number
- 1591 FDA UDI
- Primary DI / UDI-DI
- E22115911 FDA UDI
- 510(k) Number
- K083036 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing 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
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 coating, tooth-desensitizing
Profluorid L by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K083036 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VOCO GmbH
Sources (1)
- FDA UDI 83d30cac-73d6-4a31-a6c3-17950b6799fb 37 fields · synced May 30, 2026