DFV Desensitizing Varnish (Wonderful Varnish) Chocolate
DFV Desensitizing Varnish is a dental resin coating used to treat exposed dentin sensitivity and reduce sensitivity after dental procedures. The chocolate flavored configuration is intended…
DFV Desensitizing Varnish is a dental resin coating used to treat exposed dentin sensitivity and reduce sensitivity after dental procedures. The chocolate flavored configuration is intended for application by a professional clinician.
The varnish contains sodium fluoride in a resin-based liquid that is brushed onto the tooth. It forms a surface film and promotes calcium fluoride formation, helping block open dentinal tubules. Ethanol provides fluidity for application and promotes drying.
Listed Item
DFV Desensitizing Varnish (Wonderful Varnish), Chocolate 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 sealed unit-dose tray. It should not be used in patients with resin or 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 |
|---|---|---|
| 70-23 | Withdrawn |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.