3d Endo

Absorbent Paper Points Cell Pack Box/200 X-Coarse

Registry build 21.09.26
35manufacturers in China registered for this device type
60catalogue 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 3D Endo
Listed by 3D Dental Designs AND Development, LLC
FDA product code EKN
Device type Point, Paper, Endodontic
Device class Class 1
Regulation 21 CFR 872.3830
Premarket notification Exempt
Record published 2023-03-02

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for 3D Endo
Catalogue number Size Status
3D-PPC80 In distribution
3D-PPB10 In distribution
3D-PPB35 In distribution
3D-PPC15 In distribution
3D-PPC10 In distribution
3D-PPB90 In distribution
3D-PPB70 In distribution
3D-PPC60 In distribution
1 In distribution
3D-PPB30T4 In distribution
3D-PPB35T6 In distribution
3D-PPC45-80 In distribution
3D-PPB25 In distribution
3D-PPB25T4 In distribution
3D-PPBM In distribution
3D-PPB25T6 In distribution
3D-PPCXXF In distribution
3D-PPBXXF In distribution
3D-PPB35T4 In distribution
3D-PPC25 In distribution
3D-PPC50 In distribution
3D-PPB55 In distribution
3D-PPC35 In distribution
3D-PPCM In distribution
3D-PPBXF In distribution
3D-PPBXC In distribution
3D-PPB15 In distribution
3D-PPCF In distribution
3D-PPC20 In distribution
3D-PPB90-140 In distribution
3D-PPB15-40 In distribution
3D-PPB45-80 In distribution
3D-PPB40T6 In distribution
3D-PPC40 In distribution
3D-PPC30 In distribution
3D-PPB45T4 In distribution
3D-PPC15-40 In distribution
3D-PPB40 In distribution
3D-PPB4580T4 In distribution
3D-PPCXF In distribution
3D-PPB20T4 In distribution
3D-PPCXC In distribution
3D-PPC55 In distribution
3D-PPB15T4 In distribution
3D-PPB20 In distribution
3D-PPB20T6 In distribution
3D-PPCC In distribution
3D-PPB40T4 In distribution
3D-PPB45 In distribution
3D-PPB15T6 In distribution
3D-PPC45 In distribution
3D-PPB50 In distribution
3D-PPBF In distribution
3D-PPB45T6 In distribution
3D-PPB1540T6 In distribution
3D-PPB30T6 In distribution
3D-PPB60 In distribution
3D-PPBC In distribution
3D-PPB80 In distribution
3D-PPC70 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
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