Sure-Endo

Absorbent Paper Points Taper .02, Size 90-140, 200/PK

Registry build 21.09.26
35manufacturers in China registered for this device type
56catalogue 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 Sure-endo
Listed by Sure Dent Corporation, South Korea
FDA product code EKN
Device type Point, Paper, Endodontic
Device class Class 1
Regulation 21 CFR 872.3830
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-04-10
Record revised 2025-02-25 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Sure-endo
Catalogue number Size Per pack Status
20007004 100 In distribution
20001502 200 In distribution
20009002 200 In distribution
20005004 100 In distribution
20004006 100 In distribution
20014002 200 In distribution
20002002 200 In distribution
20001506 100 In distribution
20154002 200 In distribution
20001504 100 In distribution
20006006 100 In distribution
20458002 200 In distribution
20012002 200 In distribution
20001002 200 In distribution
20002502 200 In distribution
2000F200 100 In distribution
20005502 200 In distribution
20008002 200 In distribution
20008006 100 In distribution
20013002 200 In distribution
20003004 100 In distribution
20003506 100 In distribution
20005504 100 In distribution
20003002 200 In distribution
20005506 100 In distribution
2000F400 100 In distribution
20007006 100 In distribution
2000F300 100 In distribution
20010002 200 In distribution
20007002 200 In distribution
20204504 100 In distribution
20000802 200 In distribution
20008004 100 In distribution
20003006 100 In distribution
2000F100 100 In distribution
20002504 100 In distribution
20002004 100 In distribution
20004004 100 In distribution
20004002 200 In distribution
20002506 100 In distribution
20011002 200 In distribution
20005002 200 In distribution
20006002 200 In distribution
2000F500 100 In distribution
29014002 200 In distribution
20F12300 100 In distribution
20006004 100 In distribution
20003504 100 In distribution
20004502 200 In distribution
20004504 100 In distribution
20004506 100 In distribution
200F4500 100 In distribution
20005006 100 In distribution
20002006 100 In distribution
20003502 200 In distribution
20204506 100 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