Medicom Duraflor
Duraflor Varnish 5% Fluoride Bubble GUM -Tube
1manufacturer
6catalogue 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 | AMD Medicom Inc., Canada |
|---|---|
| FDA product code | LBH |
| Device type | Varnish, Cavity |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3260 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-11 |
| Record revised | 2022-04-19 (version 5) |
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 59 to 86 °F; Storage environment temperature 15 to 30 °C |
| Packaging | Pack of 6, outer case of 12 |
| Sizes | Total volume 0.25 to 10 ml |
| Distribution end date | 2023-09-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10011-US | Total Volume 10 ml | In distribution | |
| 1011-BG200 | Total Volume 0.25 ml | 200 | In distribution |
| 1011-BG32 PK6 | Total Volume 0.25 ml | 32 | In distribution |
| SP-1011 | Total Volume 0.25 ml | 2 | In distribution |
| 1011-RB32 PK6 | Total Volume 0.4 ml | 32 | Withdrawn |
| 1011-RB200 | Total Volume 0.4 ml | 200 | Withdrawn |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 |
| 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
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.