DFV Desensitizing Varnish (Wonderful Varnish) Spearmint
DFV Desensitizing Varnish in Spearmint flavour is a fluoride-containing resin coating for treating dentinal hypersensitivity and reducing postoperative sensitivity. A professional clinician…
DFV Desensitizing Varnish in Spearmint flavour is a fluoride-containing resin coating for treating dentinal hypersensitivity and reducing postoperative sensitivity. A professional clinician applies the viscous liquid to the tooth with a brush or similar applicator, where it forms a protective film over compromised surfaces and open dentinal tubules.
Sodium fluoride supplies fluoride ions for calcium-fluoride formation, while the rosin-based film helps occlude dentinal tubules. Ethanol gives the mixture fluidity and promotes drying on the tooth surface. The formulation also contains film-forming polyamide, silica thickener, sweeteners and flavouring agents.
Listed Item
DFV Desensitizing Varnish (Wonderful Varnish), Spearmint flavor, is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Supply and Restrictions
The varnish and applicator are supplied in a foil-sealed unit-dose tray. Patients with allergy or hypersensitivity to natural resin or colophony should avoid the product, and direct ingestion should be avoided. The stated shelf life is two years.
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 |
|---|---|---|
| 70-22 | Withdrawn |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.