ProShape Paper Points ISO 35.04
2 catalogue numbers from PSPP3504, listed by Endo Direct, LLC, United States, under Point, Paper, Endodontic. 35 manufacturers in China are registered for this product code.
35manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (5), Shanghai (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Dentsply Dental (Tianjin) Co., Ltd. | Teda | Tianjin | Contract manufacturer | 2 |
| Tianjin Diadent Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 2 |
| Bazhou City Xin an Town Hexin Medical Material Factory | Hebei | Hebei | Contract manufacturer | 1 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
Showing 12 of 35. All 35 manufacturers in China registered for Point, Paper, Endodontic
Record
| Listed by | Endo Direct, LLC, United States |
|---|---|
| FDA product code | EKN |
| Device type | Point, Paper, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3830 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2024-08-02 |
| Record revised | 2024-11-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Distribution end date | 2024-11-14 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSPP3504 | In distribution | |
| PSPPF1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Absorbent Paper Points | Diadent Group Intl., Inc. | 1,092 |
| MM Marked Paper Points | Diadent Group Intl., Inc. | 644 |
| Henry Schein | Henry Schein, Inc. | 198 |
| Safco absorbent points | Safco Dental Supply | 136 |
| Zarc | Shanghai Xing YU Medical Equipment Co., Ltd. | 110 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 106 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 96 |
| Hygenic® Paper Points | Coltène/Whaledent AG | 73 |
| Endodontic Absorbent Paper Points | Tulsa Dental Products LLC | 71 |
| Top Quality Manufacturing | TOP Quality Manufacturing, Inc. | 63 |
| 3D Endo | 3D Dental Designs AND Development, LLC | 60 |
| Avalon Biomed | Shanghai Xing YU Medical Equipment Co., Ltd. | 58 |
Showing 12 of 471. All products under Point, Paper, Endodontic
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.