DFV Desensitizing Varnish (Wonderful Varnish) Marshmallow
DFV Desensitizing Varnish in marshmallow flavor is applied to teeth to treat dentinal hypersensitivity and reduce sensitivity after dental procedures. It forms a coating over exposed…
DFV Desensitizing Varnish in marshmallow flavor is applied to teeth to treat dentinal hypersensitivity and reduce sensitivity after dental procedures. It forms a coating over exposed dentin, including open dentinal tubules.
The resin-based preparation contains 5% sodium fluoride. The varnish and fluoride-derived material help occlude dentinal tubules, while ethanol gives the liquid its application consistency and helps it dry rapidly on the tooth surface.
Listed Item
DFV Desensitizing Varnish (Wonderful Varnish), Marshmallow flavor, is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Professional Application
A clinician applies a thin coat using the supplied applicator. The varnish and brush are packaged together in a sealed unit-dose tray. It should be avoided in patients with colophony hypersensitivity, stomatitis, or ulcerative gingivitis.
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 | Scientific Pharmaceuticals, Inc., United States |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K192381 |
| Record published | 2022-01-19 |
| Record revised | 2023-12-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 73 °F |
| Distribution end date | 2022-01-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70-24 | Withdrawn |
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 |
| Profisil | Kettenbach Gmbh & Co KG | 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 |
Showing 12 of 282. All products under Varnish, Cavity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192381 | 2020-02-18 |
| K982915 | 1999-02-12 |
| K983305 | 1998-12-17 |
| K900946 | 1990-05-25 |
| K860633 | 1986-04-11 |
| K852755 | 1985-09-23 |
| K852756 | 1985-07-31 |
| K802926 | 1980-12-19 |
| K800438 | 1980-03-12 |
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.