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VOCO Profluorid Varnish
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 2241Model single dose
by VOCO GmbH
Identity
- Trade Name
- VOCO Profluorid Varnish EUDAMEDFDA UDI
- Generic Name
- Dental unfilled resin sealant/coating FDA UDI
- Device Name
- VOCO Profluorid Varnish EUDAMEDFluoride-containin dental desensitising varnish (5% NaF) FDA UDI
- Model / Reference
- 2241 EUDAMEDFDA UDIsingle dose EUDAMED
- Description
- Fluoride-containin dental desensitising varnish (5% NaF) FDA UDI
Identifiers
- Catalog Number
- 2241 FDA UDI
- Primary DI / UDI-DI
- E22122411 EUDAMEDFDA UDI
- Basic UDI-DI
- B-E22122411 EUDAMED
- FDA Product Code
- LBH FDA UDI
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
- GMDN Term
- Dental unfilled resin sealant/coating FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3260 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 unfilled resin sealant/coating
VOCO Profluorid Varnish by VOCO GmbH — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental unfilled resin sealant/coating.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA UDI 4035622f-fcaf-4989-85c0-564ec4ac95c7 36 fields · synced Oct 6, 2026
- EUDAMED 466832d7-2509-4d44-93c2-682b11af320d 61 fields · synced Oct 6, 2026