NuSmile NuNamel Varnish
NuSmile NuNamel Varnish Unit Dose 200 pk Kit - Strawberry
1manufacturer
12catalogue numbers in this listing
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 | Nusmile, Ltd, United States |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K132109 |
| Record published | 2025-03-18 |
| Record revised | 2025-07-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NNVS50 | In distribution | |
| NNVS200 | In distribution | |
| NNVB50 | In distribution | |
| NMNNV50 | In distribution | |
| NNVM200 | In distribution | |
| NNVB200 | In distribution | |
| NBNNV200 | In distribution | |
| NMNNV200 | In distribution | |
| NNVM50 | In distribution | |
| NBGNNV50 | In distribution | |
| NBGNNV200 | In distribution | |
| NBNNV50 | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ultradent Products Inc. | 510(k) number | 2018-07-12 | Class II | Mixed-up of materials/components | Dental varnish has the possibility of having an unpleasant and off flavor. | 1654 units | 2019-02-19 |
| 3M Company | 510(k) number | 2018-07-06 | Class II | Mixed-up of materials/components | Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. | 73 units (200 pack) | 2019-02-26 |
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.