Temp-Bond Original
Automix Syringes and Mixing Tips
6manufacturers in China registered for this device type
1catalogue number
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 | Kerr Corporation, United States |
|---|---|
| FDA product code | EMB |
| Device type | Zinc Oxide Eugenol |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-05-26 |
| Record revised | 2025-08-18 (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, manufacturing date |
| Storage | Storage environment temperature 2 to 25 °C |
| Sizes | Weight 23.6 g |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 33215 | Weight 23.6 g | 2 | In distribution |
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 |
| Zinc Oxide U.S.P. | Dentsply LLC | 2 |
| Embonte + | Kerr Corporation | 2 |
| Waterpik Krex Z.O.E. Impression Corrective Paste | Water PIK, Inc. | 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.