3d Endo

Paste Fillers SS 25mm #25-40 Latch type PK/4

Registry build 21.09.26
53manufacturers in China registered for this device type
283catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (13), Jiangsu (8), Shanghai (7). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EKS
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
Suzhou Pac-Dent Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 26
Denjoy Dental Co., Ltd. Changsha Hunan Contract manufacturer 17
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Shenzhen Superline Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 12
Wuhu Guli Ortho Co., Ltd. Wuhu Anhui Contract manufacturer 12
Shenzhen Forever Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9
Zhejiang Eksen Medical Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 9
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66

Showing 12 of 53. All 53 manufacturers in China registered for File, Pulp Canal, Endodontic

Record

Regulatory record for 3D Endo
Listed by 3D Dental Designs AND Development, LLC
FDA product code EKS
Device type File, Pulp Canal, Endodontic
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2023-02-20

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Label carries lot or batch number
Distribution end date 2023-02-20
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for 3D Endo
Catalogue number Size Status
KS2515-40 In distribution
RS2570 In distribution
KN3120 In distribution
RS3170 In distribution
HS2540 In distribution
HN2180 In distribution
KN2108 In distribution
KS2508 In distribution
RS2508 In distribution
PF2125 In distribution
HN3130 In distribution
KN2115 In distribution
RS2555 In distribution
KN2525 In distribution
HS3160 In distribution
HS2125 In distribution
PF2535 In distribution
KS2510 In distribution
KS2570 In distribution
KS3170 In distribution
HS3170 In distribution
RS2130 In distribution
HN2145 In distribution
KN3145-80 In distribution
HN3115 In distribution
HS2150 In distribution
RS3145 In distribution
RS2545-80 In distribution
PF2525 In distribution
KS2108 In distribution
HN3110 In distribution
KS3115 In distribution
KS3135 In distribution
KN3160 In distribution
PF2530 In distribution
HN2525 In distribution
KN3170 In distribution
HS2525 In distribution
HN2120 In distribution
KS2545-80 In distribution
KS3150 In distribution
HS2535 In distribution
KN2130 In distribution
PF2135 In distribution
RS2125 In distribution
RS3135 In distribution
KS2160 In distribution
HS3155 In distribution
RS3125 In distribution
HN2510 In distribution
HN2555 In distribution
KN2145-80 In distribution
HS2106 In distribution
HS2506 In distribution
HN3108 In distribution
KN2115-40 In distribution
KN3180 In distribution
HS2580 In distribution
RS3150 In distribution
HN2145-80 In distribution
RS2150 In distribution
KS2130 In distribution
KN2555 In distribution
HS2180 In distribution
HN2515-40 In distribution
KN2535 In distribution
RS2115-40 In distribution
HN2570 In distribution
HS2520 In distribution
RS2545 In distribution
KS2140 In distribution
RS3115-40 In distribution
HN3115-40 In distribution
RS2506 In distribution
HS2515 In distribution
KS2535 In distribution
HN2130 In distribution
HN2108 In distribution
RS3115 In distribution
HN2170 In distribution
HS2108 In distribution
KN2570 In distribution
HS2525 In distribution
HS3115 In distribution
RS2540 In distribution
KS2110 In distribution
HS2115 In distribution
HS3108 In distribution
HS2145-80 In distribution
KN3140 In distribution
RS2120 In distribution
HN3180 In distribution
HS2170 In distribution
HN3120 In distribution
PF2125-40 In distribution
KS2125 In distribution
HS2530 In distribution
HS3125 In distribution
KN3150 In distribution
KN3115-40 In distribution
RS2160 In distribution
RS3106 In distribution
RS2135 In distribution
KS2170 In distribution
HN2530 In distribution
HS2560 In distribution
RS3120 In distribution
HN3135 In distribution
HN2508 In distribution
HN2160 In distribution
RS3155 In distribution
HN2540 In distribution
HS3140 In distribution
KN2510 In distribution
KN2580 In distribution
KN3115 In distribution
KN3135 In distribution
KS2155 In distribution
HS2570 In distribution
KN2545-80 In distribution
KN3145 In distribution
RS3130 In distribution
HS2155 In distribution
KN2545 In distribution
KS2540 In distribution
RS2580 In distribution
KS2525 In distribution
KS2515 In distribution
HN2115-40 In distribution
HN3170 In distribution
KN2515 In distribution
KS3145 In distribution
HS2545-80 In distribution
HN3145-80 In distribution
KS3180 In distribution
KN2520 In distribution
RS2180 In distribution
KN2125 In distribution
HS2115-40 In distribution
KN2508 In distribution
RS2550 In distribution
HS2110 In distribution
KN3155 In distribution
HS2145 In distribution
RS2115 In distribution
HN2125 In distribution
HN2545-80 In distribution
HN2580 In distribution
KS2106 In distribution
KN2515-40 In distribution
RS2106 In distribution
RS3140 In distribution
HN2140 In distribution
RS3108 In distribution
HN3155 In distribution
HS2120 In distribution
HN2115 In distribution
HN2545 In distribution
KN3125 In distribution
KS3145-80 In distribution
KS3120 In distribution
HS2550 In distribution
KN2530 In distribution
RS2155 In distribution
KS2115-40 In distribution
HS3150 In distribution
HN3125 In distribution
RS3160 In distribution
RS2560 In distribution
RS2510 In distribution
HN3150 In distribution
HS2515-40 In distribution
KS3110 In distribution
KN3130 In distribution
KS3125 In distribution
KS2520 In distribution
HN3140 In distribution
RS2525 In distribution
RS2535 In distribution
RS2140 In distribution
HS2555 In distribution
KN2540 In distribution
KS2555 In distribution
KN2120 In distribution
HS2510 In distribution
HS3120 In distribution
HN2110 In distribution
HN2515 In distribution
KS3115-40 In distribution
KN2180 In distribution
PF2130 In distribution
RS3180 In distribution
HS3145 In distribution
KS2580 In distribution
KN2135 In distribution
RS2108 In distribution
KN2110 In distribution
KS3130 In distribution
RS2145-80 In distribution
HN3145 In distribution
HS3130 In distribution
KN2560 In distribution
RS2145 In distribution
RS3110 In distribution
KS3108 In distribution
RS2520 In distribution
HN2135 In distribution
HS2160 In distribution
HS2545 In distribution
RS2530 In distribution
PF2525-40 In distribution
KS2560 In distribution
HS3115-40 In distribution
KS2545 In distribution
KN3108 In distribution
KS2530 In distribution
KN2550 In distribution
RS3145-80 In distribution
HS3110 In distribution
KS2550 In distribution
KS2135 In distribution
RS2110 In distribution
KS3140 In distribution
KS3155 In distribution
PF2140 In distribution
RS2170 In distribution
HS3180 In distribution
HN2150 In distribution
HN3160 In distribution
KN2145 In distribution
HN2520 In distribution
KS2120 In distribution
HN2155 In distribution
HN2550 In distribution
KS3160 In distribution
HS2140 In distribution
KN2155 In distribution
HS3145-80 In distribution
HS3135 In distribution
RS2515-40 In distribution
KS2145 In distribution
KN2150 In distribution
KS2506 In distribution
KS2115 In distribution
HS2135 In distribution
HN2535 In distribution
KS2180 In distribution
KN2170 In distribution
KN2160 In distribution
HS2508 In distribution

Showing 250 of 283 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Henry Schein Henry Schein, Inc. 720
Integra® Miltex® Integra LifeSciences Production Corporation 658
Endodontic Hand Instruments Tulsa Dental Products LLC 612
Brasseler USA Peter Brasseler Holdings, LLC 526
Darby Dental Supply, LLC Darby Dental Supply, LLC 456
Avalon Biomed Shenzhen Denco Medical Co., Ltd. 233
KP Guilin Kevin Peter Technology Co., Ltd. 216
Dctaper SS White Burs LLC 205
Advance Dental Products THE Atlanta Dental Supply Company 205
Edge File US Endodontics, LLC 202
Komet Root Canal Files Gebr. Brasseler Gmbh & Co. KG 199
K-Files Diadent Group Intl., Inc. 188

Showing 12 of 1,536. All products under File, Pulp Canal, 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