MI Varnish™
MI Varnish is a dental fluoride varnish with a desensitizing action when applied to tooth surfaces. It contains 5% sodium fluoride with casein phosphopeptide-amorphous calcium phosphate,…
MI Varnish is a dental fluoride varnish with a desensitizing action when applied to tooth surfaces. It contains 5% sodium fluoride with casein phosphopeptide-amorphous calcium phosphate, also called CPP-ACP.
The paste is packaged in unit doses and applied with a disposable brush. Application leaves a visible varnish film, helping the clinician observe where the material has been placed.
Listed Item
MI Varnish™ Fresh Strawberry, 50 unit doses , 0.55g (0.5 mL), 50 disposable green applicators
Formulation
The varnish includes a rosin-derived adhesive component and a solvent supporting its resin formulation. Its stated use is desensitization of teeth through topical application. The listed strawberry presentation supplies unit doses and disposable applicators for that application.
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 | GC America Inc., United States |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Contract manufacturer, Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K102808 |
| Record published | 2022-07-05 |
| Record revised | 2019-02-07 (version 4) |
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 8 to 25 °C; Storage environment temperature 46 to 77 °F |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 005265 | 50 | In distribution | |
| 004274 | 50 | In distribution | |
| 442505 | 50 | In distribution | |
| 442505 | 50 | In distribution | |
| 005265 | 50 | In distribution | |
| 442500 | 50 | In distribution | |
| 004274 | 50 | In distribution | |
| 442500 | 50 | 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 |
| 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 |
|---|---|
| K102808 | 2010-12-22 |
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.