Top Quality Manufacturing

TQMPL Smart-Taper Absorbent Paper Points - F1-F3 - Assorted - 28 mm

Registry build 21.09.26
35manufacturers in China registered for this device type
63catalogue 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 Top Quality Manufacturing
Listed by TOP Quality Manufacturing, Inc.
FDA product code EKN
Device type Point, Paper, Endodontic
Device class Class 1
Regulation 21 CFR 872.3830
Premarket notification Exempt
Record published 2024-10-28
Record revised 2026-05-14 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date
Distribution end date 2026-05-13
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Top Quality Manufacturing
Catalogue number Size Per pack Status
18009121 100 In distribution
18009102 200 In distribution
18009124 100 In distribution
18009118 100 In distribution
18009109 200 In distribution
18009120 100 In distribution
18009122 100 In distribution
18009116 100 In distribution
12609263 60 In distribution
18009127 100 In distribution
18009106 200 In distribution
18009132 100 In distribution
18009115 100 In distribution
12609254 60 In distribution
18009101 200 In distribution
18009108 200 In distribution
12609265 60 In distribution
12609261 60 In distribution
12609259 60 In distribution
12609249 60 In distribution
12609251 60 In distribution
12609245 60 In distribution
12609242 60 In distribution
18009119 100 In distribution
18009117 100 In distribution
12609247 60 In distribution
18009113 200 In distribution
18009110 200 In distribution
12609260 60 In distribution
18009125 100 In distribution
18009128 100 In distribution
18009129 100 In distribution
18009103 200 In distribution
18009131 100 In distribution
12609267 60 In distribution
18009134 100 In distribution
18009107 200 In distribution
18009123 100 In distribution
18009114 200 In distribution
18009104 200 In distribution
18009133 100 In distribution
12609246 60 In distribution
18009126 100 In distribution
18009111 200 In distribution
18009130 100 In distribution
18009112 200 In distribution
18009105 200 In distribution
12609248 60 In distribution
12609262 60 Withdrawn
12609250 60 Withdrawn
12609266 60 Withdrawn
12609258 60 Withdrawn
12609244 60 Withdrawn
12609264 60 Withdrawn
12609241 60 Withdrawn
12609257 60 Withdrawn
12609255 60 Withdrawn
12609252 60 Withdrawn
12609269 60 Withdrawn
12609268 60 Withdrawn
12609256 60 Withdrawn
12609243 60 Withdrawn
12609253 60 Withdrawn

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
Endodontic Absorbent Paper Points Tulsa Dental Products LLC 71
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