Profisil
Profisil Fluoride Varnish is designed to adhere to tooth surfaces for several hours while releasing fluoride ions. The filing describes a 5% sodium fluoride formulation suspended in a…
Profisil Fluoride Varnish is designed to adhere to tooth surfaces for several hours while releasing fluoride ions. The filing describes a 5% sodium fluoride formulation suspended in a dimethicone gel.
The listed product variants include combination and normal packs, mint, berry and unflavored versions, plus a sample pack. The device family is described as a sodium-fluoride varnish for dentinal hypersensitivity.
Listed Item
Profisil Fluoride Varnish Plus Combi pack, 30 x 0,5 ml, (10 xMint, 10 xBerry, 10 xUnflavored)
Dental Use
The listed packs distinguish combination and normal formats, flavors and a sample pack. The filing describes dentinal-hypersensitivity treatment through mechanical occlusion of dentinal tubules.
Who Else Makes It
Registered in Hebei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| CAO (China) Medical Equipment Company, Limited | Langfang | Hebei | Contract manufacturer | 6 |
Record
| Listed by | Kettenbach Gmbh & Co KG, Germany |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K230333 |
| Record published | 2025-04-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14829 | In distribution | |
| 14801 | In distribution | |
| 14807 | In distribution | |
| 14804 | In distribution | |
| 14809 | In distribution | |
| 14831 | In distribution | |
| 14812 | In distribution | |
| 14800 | In distribution | |
| 14832 | In distribution | |
| 14810 | In distribution | |
| 14806 | In distribution | |
| 14826 | In distribution | |
| 14821 | In distribution | |
| 14830 | In distribution | |
| 14827 | In distribution | |
| 14802 | In distribution | |
| 14808 | In distribution | |
| 14803 | In distribution | |
| 14824 | In distribution | |
| 14820 | In distribution | |
| 14822 | In distribution | |
| 14828 | In distribution | |
| 14811 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| NovaBright | Nanova BIO Materials Inc | 46 |
| Enamelast | Ultradent Products Inc. | 41 |
| Nupro® | Dentsply Professional | 34 |
| Fluorodose | Centrix, Inc. | 26 |
| VarnishAmerica | Medical Products Laboratories, Inc. | 24 |
| Voco Profluorid Varnish | Voco Gmbh | 23 |
| Starbright | Nanova BIO Materials Inc | 22 |
| Wonderful Dental | Roses and Rubies, LLC | 19 |
| Henry Schein | Henry Schein, Inc. | 19 |
| Waterpik Ultra Thin & Clear Varnish | Water PIK, Inc. | 18 |
| Premier | Premier Dental Products Co. | 17 |
| D-Lish | Young Dental Manufacturing I, LLC | 17 |
Showing 12 of 282. All products under Varnish, Cavity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262243 | 2026-09-03 |
| K230333 | 2023-07-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.