Hygenic® Paper Points
HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 20 - 45
35manufacturers in China registered for this device type
73catalogue 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 | Coltène/Whaledent AG, Switzerland |
|---|---|
| FDA product code | EKN |
| Device type | Point, Paper, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3830 |
| Premarket notification | Exempt |
| Record published | 2022-09-22 |
| Record revised | 2025-02-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: keep dry; Special storage condition: keep away from sunlight; Storage environment temperature 2 to 25 °C; Storage environment temperature 37 to 77 °F |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H03207 | In distribution | ||
| H03191 | 180 | In distribution | |
| 60019142 | 144 | In distribution | |
| H07677 | 200 | In distribution | |
| H02120 | 200 | In distribution | |
| H03349 | 200 | In distribution | |
| 60019129 | 144 | In distribution | |
| H02113 | 200 | In distribution | |
| 60019126 | 144 | In distribution | |
| H07689 | In distribution | ||
| H02123 | 200 | In distribution | |
| 60019130 | 144 | In distribution | |
| H03185 | 180 | In distribution | |
| H07690 | In distribution | ||
| H03205 | 180 | In distribution | |
| H03201 | 180 | In distribution | |
| H07683 | 120 | In distribution | |
| H02124 | 200 | In distribution | |
| 60019132 | 144 | In distribution | |
| H03184 | 180 | In distribution | |
| H03347 | 200 | In distribution | |
| H03190 | 180 | In distribution | |
| 60019127 | 144 | In distribution | |
| 60019128 | 144 | In distribution | |
| H03204 | 180 | In distribution | |
| H03199 | In distribution | ||
| H02119 | 200 | In distribution | |
| H07688 | In distribution | ||
| H03203 | 180 | In distribution | |
| 60019136 | 144 | In distribution | |
| H07681 | 200 | In distribution | |
| H07686 | 120 | In distribution | |
| H03350 | 200 | In distribution | |
| H03198 | In distribution | ||
| H03206 | 180 | In distribution | |
| H03182 | 180 | In distribution | |
| 60019143 | In distribution | ||
| 60019134 | 144 | In distribution | |
| H03188 | 180 | In distribution | |
| H02121 | 200 | In distribution | |
| H07684 | 120 | In distribution | |
| H03180 | 200 | In distribution | |
| H02118 | 200 | In distribution | |
| H02130 | In distribution | ||
| H03202 | 180 | In distribution | |
| H03187 | 180 | In distribution | |
| 60019139 | 144 | In distribution | |
| H07682 | 200 | In distribution | |
| H07685 | 120 | In distribution | |
| 60019135 | In distribution | ||
| H03346 | 200 | In distribution | |
| H03180 | 180 | In distribution | |
| 60019141 | 144 | In distribution | |
| H03186 | 180 | In distribution | |
| H07679 | 200 | In distribution | |
| H02114 | 200 | In distribution | |
| H03183 | 180 | In distribution | |
| 60019131 | 144 | In distribution | |
| H03348 | 200 | In distribution | |
| H03181 | 180 | In distribution | |
| H02117 | 200 | In distribution | |
| H02116 | 200 | In distribution | |
| H07687 | 120 | In distribution | |
| H03351 | In distribution | ||
| 60019138 | 144 | In distribution | |
| H07680 | 200 | In distribution | |
| 60019140 | 144 | In distribution | |
| H03189 | 180 | In distribution | |
| 60019133 | 144 | In distribution | |
| H02131 | In distribution | ||
| H02115 | 200 | In distribution | |
| H03345 | 200 | In distribution | |
| H07678 | 200 | In distribution |
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 |
| 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 |
| Sure-endo | Sure Dent Corporation | 56 |
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.