SSW Endo

Exacttaper Paper Point SX-S1-S2-F1-F2-F3 28MM Assorted - 60 Pack

Registry build 21.09.26
35manufacturers in China registered for this device type
29catalogue 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 SSW Endo
Listed by SS White Burs LLC, United States
FDA product code EKN
Device type Point, Paper, Endodontic
Device class Class 1
Regulation 21 CFR 872.3830
Establishment Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2025-02-18
Record revised 2025-05-07 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for SSW Endo
Catalogue number Size Status
U-PPTFHLG In distribution
UPPTG3004 In distribution
U-PPTFHMD In distribution
U-PPTFHPR In distribution
UPPTG3006 In distribution
U-PPTFHAS In distribution
UPPTG2504 In distribution
UPPTG4504 In distribution
UPPTG4506 In distribution
UPPTG2006 In distribution
UPPTG2004 In distribution
U-PPTTUF5 In distribution
U-PPTTUAS In distribution
UPPTG3504 In distribution
UPPTG3506 In distribution
UPPTGAS06 In distribution
UPPTG1504 In distribution
U-PPTTUF4 In distribution
UPPTG4004 In distribution
UPPTG5004 In distribution
U-PPTTUF1 In distribution
U-PPTTUF3 In distribution
UPPTG5006 In distribution
U-PPTFHSM In distribution
UPPTG2506 In distribution
U-PPTTUF2 In distribution
UPPTGAS04 In distribution
UPPTG1506 In distribution
UPPTG4006 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
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.

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