Ormco Premium

1/4 inch PADS FOR ADHESIVE REMOVING PLIERS

Registry build 21.09.26
28manufacturers in China registered for this device type
38catalogue 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 Ormco Premium
Listed by Ormco Corporation, United States
FDA product code JEX
Device type Plier, Orthodontic
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-10-31

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Dry Heat Sterilization, Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Ormco Premium
Catalogue number Size Status
866-2013 In distribution
866-2037 In distribution
866-2017 In distribution
866-2039 In distribution
866-2047 In distribution
866-2043 In distribution
866-2046 In distribution
866-2036 In distribution
866-2022 In distribution
866-2050 In distribution
866-2049 In distribution
866-2056 In distribution
866-2021 In distribution
866-2057 In distribution
866-2030 In distribution
866-2058 In distribution
866-2040 In distribution
866-2042 In distribution
866-2029 In distribution
866-2014 In distribution
866-2026 In distribution
866-2020 In distribution
866-2061 In distribution
866-2034 In distribution
866-2019 In distribution
866-2027 In distribution
866-2033 In distribution
866-2048 In distribution
866-2059 In distribution
866-2044 In distribution
866-2045 In distribution
866-2038 In distribution
866-2041 In distribution
866-2018 In distribution
866-2031 In distribution
866-2023 In distribution
866-2016 In distribution
866-2024 In distribution

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
Orthosource Orthosource, Inc. 103
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

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