Channels

Channels One Gutta Percha Points Primary

Registry build 21.09.26
35manufacturers in China registered for this device type
43catalogue 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 Channels
Listed by Henry Schein, Inc., United States
FDA product code EKN
Device type Point, Paper, Endodontic
Device class Class 1
Regulation 21 CFR 872.3830
Premarket notification Exempt
Record published 2022-08-05

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, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Channels
Catalogue number Size Per pack Status
2020627 60 In distribution
2020609 120 In distribution
2020618 60 In distribution
2020625 60 In distribution
2020604 120 In distribution
2020607 120 In distribution
2020613 60 In distribution
2020591 120 In distribution
2020633 60 In distribution
2020611 60 In distribution
2020629 120 In distribution
2020596 120 In distribution
2020617 60 In distribution
2020603 120 In distribution
2020605 120 In distribution
2020600 120 In distribution
2020619 60 In distribution
2020614 60 In distribution
2020630 120 In distribution
2020615 60 In distribution
2020616 60 In distribution
2020602 120 In distribution
2020624 60 In distribution
2020592 120 In distribution
2020598 120 In distribution
2020599 120 In distribution
2020601 120 In distribution
2020622 60 In distribution
2020626 60 In distribution
2020632 60 In distribution
2020594 120 In distribution
2020597 120 In distribution
2020606 120 In distribution
2020623 60 In distribution
2020631 120 In distribution
2020595 120 In distribution
2020610 60 In distribution
2020612 60 In distribution
2020620 60 In distribution
2020634 60 In distribution
2020593 120 In distribution
2020635 60 In distribution
2020628 120 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