Leone SPA

MICRO END CUTTER FOR LIGATURES MAX 0,3mm

Registry build 21.09.26
28manufacturers in China registered for this device type
104catalogue 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 Leone SPA
Listed by Leone SPA, Italy
FDA product code JEX
Device type Plier, Orthodontic
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-05-05
Record revised 2022-01-18 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Leone SPA
Catalogue number Size Status
P1450-00 In distribution
P1130-00 In distribution
P1905-00 In distribution
A0557-13 In distribution
P4922-00 In distribution
P4914-00 In distribution
P1621-00 In distribution
X0021 In distribution
F4900-60 In distribution
P1090-00 In distribution
P4924-00 In distribution
P4162-00 In distribution
P1919-00 In distribution
P1904-00 In distribution
P2108-00 In distribution
A0556-12 In distribution
P4921-00 In distribution
P1911-00 In distribution
P1903-00 In distribution
A0556-90 In distribution
P1922-00 In distribution
P1921-00 In distribution
P2109-00 In distribution
P1453-00 In distribution
P4917-00 In distribution
F6200-04 In distribution
A0558A90 In distribution
P4912-00 In distribution
A0556-00 In distribution
P1156-00 In distribution
P4154-00 In distribution
F4900-03 In distribution
P1914-00 In distribution
P4075-00 In distribution
P4911-00 In distribution
P4161-00 In distribution
P1916-00 In distribution
A0557-01 In distribution
F6100-04 In distribution
P4919-00 In distribution
P1155-00 In distribution
P4915-00 In distribution
A0558-00 In distribution
F4900-04 In distribution
P4163-00 In distribution
P1907-00 In distribution
P4923-00 In distribution
F4900-05 In distribution
P1090-01 In distribution
P1509-00 In distribution
P1073-00 In distribution
P4160-00 In distribution
F4900-01 In distribution
A0557-02 In distribution
A0558A00 In distribution
P2103-00 In distribution
A1730-08 In distribution
P4920-00 In distribution
P1154-00 In distribution
P1900-00 In distribution
P1451-00 In distribution
P4219-00 In distribution
P1909-00 In distribution
P4910-00 In distribution
F4900-06 In distribution
P2106-00 In distribution
P2105-00 In distribution
A0557-03 In distribution
A0557P02 In distribution
P2104-00 In distribution
P2101-00 In distribution
P1075-01 In distribution
P1452-00 In distribution
A1763-04 In distribution
P1901-00 In distribution
P1918-00 In distribution
K0950-00 In distribution
A0557-00 In distribution
P1915-00 In distribution
P2000-02 In distribution
P4918-00 In distribution
P4913-00 In distribution
P1910-00 In distribution
F4900-02 In distribution
P1902-00 In distribution
X0047 In distribution
P4089-00 In distribution
P4916-00 In distribution
P1908-00 In distribution
P1026-00 In distribution
P1917-00 In distribution
P4422-00 In distribution
A0556-01 In distribution
P2000-01 In distribution
A0558-01 In distribution
P2102-00 In distribution
P2107-00 In distribution
P4909-00 In distribution
P1920-00 In distribution
P1352-00 In distribution
P1906-00 In distribution
P4906-00 In distribution
P2110-00 In distribution
P1923-00 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
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
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