Identity
- Trade Name
- Profisil FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- Profisil Fluoride Varnish Plus Unflavored, Superbulk, 1000 x 0,5 ml, Unflavored FDA UDI
- Model / Reference
- 14832 FDA UDI
- Description
- Profisil Fluoride Varnish Plus Unflavored, Superbulk, 1000 x 0,5 ml, Unflavored FDA UDI
Identifiers
- Catalog Number
- 14832 FDA UDI
- Primary DI / UDI-DI
- E217148321 FDA UDI
- 510(k) Number
- K230333 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing, professional 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
Category: Dental coating, tooth-desensitizing, professional
Profisil by Kettenbach GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental coating, tooth-desensitizing, professional.
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Cleared under the same submission
K230333 also covers:
- Profisil — Kettenbach GmbH & Co. KG
- Profisil — Kettenbach GmbH & Co. KG
- Profisil — Kettenbach GmbH & Co. KG
- Profisil — Kettenbach GmbH & Co. KG
- Profisil — Kettenbach GmbH & Co. KG
- Profisil — Kettenbach GmbH & Co. KG
- Profisil — Kettenbach GmbH & Co. KG
- Profisil — Kettenbach GmbH & Co. KG
- Profisil — Kettenbach GmbH & Co. KG
- Profisil — Kettenbach GmbH & Co. KG
- Profisil — Kettenbach GmbH & Co. KG
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
- Kettenbach GmbH & Co. KG
Sources (1)
- FDA UDI 1d26b251-8822-42fb-820b-65cddc4fc7c2 37 fields · synced Jun 8, 2026