Fluorodose
Fluorodose Draganberry Vanrish, 1200pk
1manufacturer
26catalogue numbers in this listing
5510(k) clearances naming this product code
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 | Centrix, Inc., United States |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2018-03-29 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 700001 | In distribution | |
| 360142 | In distribution | |
| 360107 | In distribution | |
| 360112 | In distribution | |
| 360141 | In distribution | |
| 870060 | In distribution | |
| 360087 | In distribution | |
| 360078 | In distribution | |
| 360126 | In distribution | |
| 360143 | In distribution | |
| 870039 | In distribution | |
| 360086 | In distribution | |
| 360137 | In distribution | |
| 360127 | In distribution | |
| 360111 | In distribution | |
| 360109 | In distribution | |
| 360108 | In distribution | |
| 360139 | In distribution | |
| 360110 | In distribution | |
| 360106 | In distribution | |
| 360125 | In distribution | |
| 360105 | In distribution | |
| 360138 | In distribution | |
| 360077 | In distribution | |
| 360124 | In distribution | |
| 360140 | 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 |
| 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 |
| D-Lish | Young Dental Manufacturing I, LLC | 17 |
Showing 12 of 282. All products under Varnish, Cavity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250714 | 2025-11-21 |
| K120176 | 2012-07-25 |
| K021131 | 2002-09-26 |
| K992629 | 1999-10-22 |
| K981972 | 1998-12-07 |
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.