DFV Desensitizing Varnish (Wonderful Varnish) Bubblegum (Tutti-Fruity)
DFV Desensitizing Varnish is a professionally applied dental coating for dentinal hypersensitivity and sensitivity after dental treatment. This configuration is the bubblegum flavored…
DFV Desensitizing Varnish is a professionally applied dental coating for dentinal hypersensitivity and sensitivity after dental treatment. This configuration is the bubblegum flavored varnish, supplied with an applicator in a sealed unit-dose tray.
The viscous resin preparation contains sodium fluoride and forms a film over the tooth surface. The resin film and calcium fluoride formed from the fluoride ions help occlude exposed dentinal tubules, while ethanol supports application and drying.
Listed Item
DFV Desensitizing Varnish (Wonderful Varnish), Bubblegum (Tutti-Fruity) flavor, is a fluoride-containing resin preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Clinical Limitations
It should be avoided in patients with colophony or resin 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 |
|---|---|---|
| 70-21 | Withdrawn |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.