Prophylactic Strip
Prophylactic Strips - 10 Units (EN)
13manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Perfect Group Corp. Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| Guangdong Okay Technology Co., Ltd. | Zhong Shan | Guangdong | Manufacturer | 10 |
| Shurcon Manufacturing Company | Jia Shan | Zhejiang | Manufacturer | 10 |
| Weihai Jieshi Commodity Manufacture Co., Ltd. | Weihai | Shandong | Manufacturer | 10 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Shenzhen Samo Technology Co., Limited | Shenzhen | Guangdong | Manufacturer | 9 |
Showing 12 of 13. All 13 manufacturers in China registered for Instrument, Hand, Calculus Removal
Record
| Listed by | TDV Dental Ltda, Brazil |
|---|---|
| FDA product code | ELA |
| Device type | Instrument, Hand, Calculus Removal |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0009010101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 1,041 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 47 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 42 |
| Burkhart Dental | Nordent Manufacturing Inc | 21 |
| Henry Schein Acclean | Henry Schein, Inc. | 18 |
| Karl Hammacher Gmbh | Nordent Manufacturing Inc | 17 |
| Blue AND Green | Nordent Manufacturing Inc | 13 |
| Nordent Manufacturing | Nordent Manufacturing Inc | 9 |
| Safco | Nordent Manufacturing Inc | 8 |
| House Brand Dentistry | Frontier Dental Supply Inc | 4 |
| zumax | Zumax Medical Co., Ltd. | 3 |
| Stoma® | Storz AM Mark Gmbh | 3 |
Showing 12 of 16. All products under Instrument, Hand, Calculus Removal
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.