Orthosource

Samion Pin and Lig Cutter Carbide 7 Degree Angle

Registry build 21.09.26
28manufacturers in China registered for this device type
103catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (13), Shanghai (5), Guangdong (4). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JEX
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
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13
Zhejiang Eksen Medical Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 9
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Shanghai Dochem Industries Co., Ltd. Shanghai Shanghai Manufacturer 45
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Hangzhou Wise Medical Device Co., Ltd. Hangzhou Zhejiang Contract manufacturer 25
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17
Guangzhou OO Medical Scientific Limited Guangzhou Guangdong Manufacturer 17

Showing 12 of 28. All 28 manufacturers in China registered for Plier, Orthodontic

Record

Regulatory record for Orthosource
Listed by Orthosource, Inc., United States
FDA product code JEX
Device type Plier, Orthodontic
Device class Class 1
Regulation 21 CFR 872.4565
Premarket notification Exempt
Record published 2022-10-22
Record revised 2022-11-07 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, expiry date
Distribution end date 2022-10-23

Catalogue Numbers

Catalogue numbers for Orthosource
Catalogue number Size Status
713-079 In distribution
713-082 In distribution
871-147 In distribution
713-202 In distribution
871-172 In distribution
871-134 In distribution
871-109 In distribution
873-173-T In distribution
871-115 In distribution
873-179 In distribution
713-083 In distribution
873-108 In distribution
871-125 In distribution
871-148 In distribution
871-123 In distribution
713-071 In distribution
713-203 In distribution
713-204 In distribution
873-108-T In distribution
871-155 In distribution
713-076 In distribution
713-205 In distribution
871-161 In distribution
871-126 In distribution
871-173 In distribution
713-080 In distribution
873-107 In distribution
713-073 In distribution
871-131 In distribution
871-179-L In distribution
871-124 In distribution
871-101 In distribution
873-131-T In distribution
871-110 In distribution
871-157 In distribution
713-206 In distribution
873-058 In distribution
871-137 In distribution
873-142-S In distribution
873-146 In distribution
871-179 In distribution
873-140-A In distribution
871-176 In distribution
871-135 In distribution
873-110 In distribution
713-077 In distribution
713-072 In distribution
871-104 In distribution
871-118 In distribution
871-173-15 In distribution
871-107 In distribution
871-119 In distribution
871-129 In distribution
713-074 In distribution
871-114 In distribution
713-075 In distribution
873-172-T In distribution
871-128 In distribution
871-144 In distribution
713-201 In distribution
871-118G In distribution
871-151 In distribution
871-120 In distribution
871-154 In distribution
871-103 In distribution
871-172-15 In distribution
871-178 In distribution
871-146 In distribution
713-078 In distribution
871-102 In distribution
871-121 In distribution
871-152 In distribution
871-153 In distribution
713-084 In distribution
871-174-7 In distribution
871-105 In distribution
871-145 In distribution
873-122-T-C In distribution
713-081 In distribution
871-122 In distribution
871-180 Withdrawn
871-139 Withdrawn
871-142 Withdrawn
873-115-C Withdrawn
873-172-15-T Withdrawn
873-114 Withdrawn
871-133 Withdrawn
873-107-T Withdrawn
871-132 Withdrawn
873-140-S Withdrawn
873-142-L Withdrawn
873-178 Withdrawn
873-174-T Withdrawn
873-115 Withdrawn
871-174 Withdrawn
871-140 Withdrawn
871-114-C Withdrawn
873-173-7-T Withdrawn
871-115-G Withdrawn
873-131 Withdrawn
871-156 Withdrawn
871-136 Withdrawn
873-179-L Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dentronix Coltene/Whaledent Gmbh & Co. KG 165
Pomee Pomee Corporation 117
Schwert A. Schweickhardt Gmbh & Co. KG 110
Leone SPA Leone SPA 104
Power Dental USA Power Dental U.S.A. Inc. 103
HU-Friedy HU-Friedy MFG Co., LLC 102
Henry Schein Henry Schein, Inc. 95
American Eagle Instruments American Eagle Instruments 87
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 68
Plier, Orthodontic YDM Corporation 67
gSource Gsource, LLC. 64
Plier, Orthodontic Dentaurum GmbH & Co. KG 59

Showing 12 of 219. All products under Plier, Orthodontic

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