Provicol QM Plus
Catalogue number 1098, listed by Voco Gmbh, Germany, under Zinc Oxide Eugenol. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Voco Gmbh, Germany |
|---|---|
| FDA product code | EMB |
| Device type | Zinc Oxide Eugenol |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K161630 |
| Record published | 2016-10-31 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 23 °C |
| Sizes | Weight 250 g |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1098 | Weight 250 g | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161630 | 2016-09-15 |
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.