Zinc Oxide U.S.P.
Zinc Oxide U.S.P., Bottle, Powder 1.5 oz
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Jiangxi (1), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Nanchang White Technology Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 21 |
| Changsha Easyinsmile Intelligence Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
| Changshu Shangchi Dental Materials Co., Ltd. | Changshu | Jiangsu | Manufacturer | 3 |
| Shanghai Rong Xiang Dental Material Company Limited | Shanghai | Shanghai | Contract manufacturer | 1 |
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EMB |
| Device type | Zinc Oxide Eugenol |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2022-09-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Sizes | Weight 42.53 to 453.6 g |
| Distribution end date | 2018-11-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 0011803FG | Weight 42.53 g | 12 | Withdrawn |
| 0011804FG | 1 Bottle (453.6 g) | 30 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maquira | Maquira Industria de Produtos Odontologicos S/A | 6 |
| Ceka & Preci-Line Attachments | Alphadent Co., Ltd. | 4 |
| DiaCemTempNE | Diadent Group Intl., Inc. | 4 |
| ZOE B&T® Base and Temporary Filling Material | Dentsply LLC | 3 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 3 |
| Mizzy | Keystone Industries | 3 |
| Zinconol | Prevest Denpro Limited | 3 |
| SciPharm NeoZoe, Temporary Cement | Scientific Pharmaceuticals, Inc. | 2 |
| Nobil Metal SPA | Nobil Metal SPA | 2 |
| Embonte + | Kerr Corporation | 2 |
| Waterpik Krex Z.O.E. Impression Corrective Paste | Water PIK, Inc. | 2 |
| TempoCem® Automix | DMG Chemisch Pharmazeutische Fabrik Gmbh | 2 |
Showing 12 of 57. All products under Zinc Oxide Eugenol
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.