Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal …
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230333 FDA 510(k)
- FDA Product Code
- LBH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3260 FDA 510(k)
- Regulation Number
- 872.3260 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Profisil Fluoride Varnish is a dental cavity varnish designed to protect and strengthen tooth enamel by delivering fluoride. It is classified as a cavity varnish and is intended for application to dental surfaces to prevent demineralization and remineralization of enamel, reducing the risk of caries (tooth decay).
The varnish is supplied in single-use packs, including a combi pack (14801) and normal packs in mint, berry, and unflavored flavors (14802, 14804, 14806), as well as a sample pack (14800). It is non-sterile and intended for use in dental offices. The device holds FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for dental products. Packaging sizes are fixed as specified, and storage should follow manufacturer guidelines.
Frequently asked questions
What are the different flavor options available for the Profisil Fluoride Varnish, and how might they influence patient preference or compliance?
The Profisil Fluoride Varnish is available in four flavor options: mint (14802), berry (14804), unflavored (14806), and a sample pack (14800). The mint and berry flavors may appeal to patients who prefer a distinct taste, potentially improving compliance by making the application more pleasant, while the unflavored option caters to those who dislike strong flavors or have taste sensitivities. The combi pack (14801) is not flavor-specific but likely includes multiple single-use packs for versatility in patient selection.
Is the Profisil Fluoride Varnish intended for single-use only, and if so, how should unused portions be handled?
Yes, the Profisil Fluoride Varnish is supplied in single-use packs (14801, 14802, 14804, 14806, and 14800) designed for one application per pack. Since it is non-sterile and intended for dental office use, unused portions should not be saved for future use to maintain hygiene and prevent contamination. Each pack is sealed for one-time clinical application only.
What storage requirements should be followed for the Profisil Fluoride Varnish to ensure its effectiveness and shelf life?
While the exact storage instructions are not detailed in the provided data, dental products like this varnish typically require protection from extreme temperatures, moisture, and direct sunlight. The manufacturer’s guidelines (not specified here) should be followed to preserve the varnish’s stability and efficacy. Always store in a cool, dry place, away from direct light, and ensure the packaging remains intact until use.
Are there multiple sizes or models of the Profisil Fluoride Varnish, and how do they differ?
The Profisil Fluoride Varnish comes in five distinct pack types, each serving different clinical or administrative needs: the Combi pack (14801), which likely contains multiple single-use applications; Normal packs in three flavors (mint 14802, berry 14804, unflavored 14806); and a Sample pack (14800) for trial use. The combi pack and normal packs are identical in content (single-use applications) but differ in quantity and flavor, while the sample pack is presumably smaller for demonstration or testing purposes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230333 | Class II | Active |
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Manufacturer
- Manufacturer
- Kettenbach GmbH & Co. KG
Sources (2)
- FDA 510(k) K230333 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026