Integra® Miltex®
Zinc Oxide, 1.5 oz. (42.5gm) Bottle
6manufacturers in China registered for this device type
3catalogue 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 | Integra LifeSciences Production Corporation, 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-12 |
| Record revised | 2025-08-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store in a cool dry location |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 310-16300 | Withdrawn | |
| 310-16200 | Withdrawn | |
| 310-16250 | Withdrawn |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 |
| Mizzy | Keystone Industries | 3 |
| Zinconol | Prevest Denpro Limited | 3 |
| SciPharm NeoZoe, Temporary Cement | Scientific Pharmaceuticals, Inc. | 2 |
| Nobil Metal SPA | Nobil Metal SPA | 2 |
| Zinc Oxide U.S.P. | Dentsply LLC | 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.