VarnishAmerica
Fluoride Varnish, Box of 32 single dose (0.4ml) bubble gum combination
1manufacturer
24catalogue numbers in this listing
1510(k) clearance
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 | Medical Products Laboratories, Inc., United States |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2016-09-13 |
| Record revised | 2020-10-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2019-11-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00008 | Box 200 | Withdrawn |
| 00019 | Box 200 | Withdrawn |
| 00016 | Box 32 | Withdrawn |
| 00031 | Box 200 | Withdrawn |
| 00011 | Box 200 | Withdrawn |
| 00032 | Box 32 | Withdrawn |
| 00006 | Box 200 | Withdrawn |
| 00014 | Box 32 | Withdrawn |
| 00001 | Box 32 | Withdrawn |
| 00010 | Box 200 | Withdrawn |
| 00018 | Box 200 | Withdrawn |
| 00003 | Box 32 | Withdrawn |
| 00002 | Box 32 | Withdrawn |
| 00005 | Box 200 | Withdrawn |
| 00017 | Box 200 | Withdrawn |
| 00004 | Box 32 | Withdrawn |
| 00009 | Box 200 | Withdrawn |
| 00020 | Box 200 | Withdrawn |
| 00015 | Box 32 | Withdrawn |
| 00022 | Box 200 | Withdrawn |
| 00013 | Box 32 | Withdrawn |
| 00012 | Box 200 | Withdrawn |
| 00007 | Box 200 | Withdrawn |
| 00021 | Box 200 | Withdrawn |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 |
| 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 |
| D-Lish | Young Dental Manufacturing I, LLC | 17 |
Showing 12 of 282. All products under Varnish, Cavity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K040098 | 2004-02-04 |
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.