SmartPractice® Wares Tartar and Stain Remover
SmartPractice® Wares Tartar and Stain Remover, 1 Gallon
34manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (8), Jiangxi (4). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Moye Technology Co Ltd | Shenzhen | Guangdong | Contract manufacturer | 14 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Yangzhou Star Oral Care Product Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 7 |
| Kingkey MBC Life Technology Group Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 6 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Guangdong Xinuo Personal Care Products Co., Ltd. | Yunfu | Guangdong | Manufacturer | 33 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Tianjin Water Source Tech Co., Ltd. | Tianjin | Tianjin | Manufacturer | 27 |
Showing 12 of 34. All 34 manufacturers in China registered for Cleanser, Denture, Over The Counter
Record
| Listed by | Dentsply LLC, United States |
|---|---|
| FDA product code | EFT |
| Device type | Cleanser, Denture, Over The Counter |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3520 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2022-12-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Sizes | Total volume 3.8 l |
| Distribution end date | 2022-12-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 0821352FG | Total Volume 3.8 l | 4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Retainer Brite® | Dentsply Sirona Orthodontics Inc. | 10 |
| Ola Fresh Dental Appliance Cleanser | Thermoplastic Comfort SYS | 3 |
| TCS Fresh Concentrated Dental Appliance Cleaner | Thermoplastic Comfort SYS | 3 |
| Smilesaver | Soluria II LLC | 3 |
| Cleaning Crystals, Packette | Align Technology, Inc. | 2 |
| DawnMist | Dukal LLC | 2 |
| Pala | Kulzer SRL | 2 |
| Freshmint | NEW World Imports, Inc. | 2 |
| Venus | Kulzer SRL | 2 |
| Y-Kelin | Anhui Greenland Biotech Co., Ltd. | 2 |
| Efferdent | Medtech Products, Inc. | 2 |
| Dentasoak KIT-NO CUP(3 Months) | Great Lakes Dental Technologies, Ltd. | 1 |
Showing 12 of 46. All products under Cleanser, Denture, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K000996 | 2000-06-16 |
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.