Hygenic® Paper Points

HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 20 - 45

Registry build 21.09.26
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.

Chinese manufacturers registered for FDA product code EKN
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

Regulatory record for Hygenic® Paper Points
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

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 numbers for Hygenic® Paper Points
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer