Endodontic Absorbent Paper Points

Paper Points, Standard & Sterile Size ISO 20-35 Assorted

Registry build 21.09.26
35manufacturers in China registered for this device type
71catalogue 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 Endodontic Absorbent Paper Points
Listed by Tulsa Dental Products LLC, United States
FDA product code EKN
Device type Point, Paper, Endodontic
Device class Class 1
Regulation 21 CFR 872.3830
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-10-26

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: Avoid direct sunlight

Catalogue Numbers

Catalogue numbers for Endodontic Absorbent Paper Points
Catalogue number Size Per pack Status
670178 180 In distribution
AP0490 120 In distribution
670420 200 In distribution
670192 180 In distribution
670191 180 In distribution
670417 200 In distribution
670157 200 In distribution
670416 200 In distribution
BSTPULPMPP0FX 180 In distribution
670071 180 In distribution
670184 180 In distribution
670155 200 In distribution
670414 200 In distribution
670408 200 In distribution
BSTPULPMPP0F2 180 In distribution
670172 180 In distribution
670413 200 In distribution
TSTRBPPM00AST 180 In distribution
670066 180 In distribution
670418 200 In distribution
670195 180 In distribution
670188 180 In distribution
670176 180 In distribution
670419 200 In distribution
670065 180 In distribution
670189 180 In distribution
670156 200 In distribution
670194 180 In distribution
670186 180 In distribution
TSTRBPPM00050 180 In distribution
670199 180 In distribution
670175 180 In distribution
670187 180 In distribution
670190 180 In distribution
670181 180 In distribution
670411 200 In distribution
670421 200 In distribution
670412 200 In distribution
670154 200 In distribution
670197 180 In distribution
WOAPS 180 In distribution
670153 200 In distribution
TSTRBPPM00025 180 In distribution
670177 180 In distribution
670151 180 In distribution
670185 180 In distribution
WOAPP 180 In distribution
670179 180 In distribution
BSTPULPMPPAST 180 In distribution
670069 180 In distribution
670183 180 In distribution
670196 180 In distribution
WOAPL 180 In distribution
670182 180 In distribution
670193 180 In distribution
670422 200 In distribution
670067 180 In distribution
670174 180 In distribution
670409 200 In distribution
670415 200 In distribution
670198 180 In distribution
AP0460 120 In distribution
670158 200 In distribution
TSTRBPPM00040 180 In distribution
670173 180 In distribution
670410 200 In distribution
670068 180 In distribution
BSTPULPMPP0F3 180 In distribution
BSTPULPMPP0F1 180 In distribution
670180 180 In distribution
BSTPULPMPPFXL 180 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
Hygenic® Paper Points Coltène/Whaledent AG 73
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