Leone SPA

MIM Activator Tube FOR Exoral Facebow 45

Registry build 21.09.26
34manufacturers in China registered for this device type
722catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (20), Jiangsu (4), Guangdong (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 DZD
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
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13
Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Henan Baistra Medical Devices Limited Zhengzhou Henan Manufacturer 34
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
Orthguide Medical Technology (Jiangsu) Co., Ltd. Wuxi Jiangsu Contract manufacturer 17

Showing 12 of 34. All 34 manufacturers in China registered for Tube, Orthodontic

Record

Regulatory record for Leone SPA
Listed by Leone SPA, Italy
FDA product code DZD
Device type Tube, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2021-02-04

Specifications

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

Catalogue Numbers

Catalogue numbers for Leone SPA
Catalogue number Size Status
G8385-906 In distribution
G8184-902 In distribution
G8125-912 In distribution
F8385-07 In distribution
F8485-906 In distribution
F8084-913 In distribution
G8421-906 In distribution
G9620-18 In distribution
G8170-917 In distribution
G8325-903 In distribution
F8485-903 In distribution
F8385-22 In distribution
F8084-22 In distribution
G8110-917 In distribution
G8181-03 In distribution
F8085-933 In distribution
G8484-03 In distribution
G8485-07 In distribution
G8084-13 In distribution
G8125-22 In distribution
F8181-902 In distribution
X0013 In distribution
F8410-02 In distribution
F8311-26 In distribution
F8384-32 In distribution
G8125-02 In distribution
G2846-902 In distribution
G8070-917 In distribution
G8185-22 In distribution
A0761-45 In distribution
F8384-922 In distribution
F8321-06 In distribution
G9650-18 In distribution
F8085-932 In distribution
G8024-13 In distribution
F8084-03 In distribution
G8324-33 In distribution
F8070-02 In distribution
G8081-903 In distribution
F8421-917 In distribution
F8324-12 In distribution
G8084-922 In distribution
G8485-903 In distribution
F8125-902 In distribution
F8581-12 In distribution
G2847-03 In distribution
G8070-907 In distribution
F8185-03 In distribution
G8024-923 In distribution
F8481-06 In distribution
G8321-02 In distribution
F8424-933 In distribution
F8484-906 In distribution
G8021-02 In distribution
G8124-913 In distribution
G8010-17 In distribution
G8381-907 In distribution
G8321-902 In distribution
G8124-23 In distribution
F8325-913 In distribution
F8324-32 In distribution
F8424-907 In distribution
F8621-37 In distribution
F8421-17 In distribution
X0024 In distribution
G8085-923 In distribution
G8410-03 In distribution
G8384-12 In distribution
G8024-903 In distribution
G8125-922 In distribution
F8084-922 In distribution
F8621-927 In distribution
G8081-902 In distribution
G8321-16 In distribution
F8321M13 In distribution
G8181-02 In distribution
G8385-03 In distribution
G8125-23 In distribution
G8024-902 In distribution
G8324-903 In distribution
F8481-03 In distribution
G8185-913 In distribution
F8124-923 In distribution
G8024-02 In distribution
G8125-03 In distribution
G8185-03 In distribution
G8484-13 In distribution
F8484-907 In distribution
G8425-06 In distribution
F8321-03 In distribution
G0565-09 In distribution
G8321-03 In distribution
F8181-903 In distribution
G8324-932 In distribution
G8424-33 In distribution
G8424-923 In distribution
F8025-942 In distribution
G8070-03 In distribution
G8321-906 In distribution
G8084-33 In distribution
G8321-12 In distribution
G8484-923 In distribution
F8124-23 In distribution
G8085-03 In distribution
G8485-912 In distribution
G8481-907 In distribution
G8085-922 In distribution
G9650-22 In distribution
F8025-22 In distribution
F8321M17 In distribution
G8085-913 In distribution
F8384-902 In distribution
F8421-907 In distribution
G8421-02 In distribution
F8024-12 In distribution
G8385-07 In distribution
G8121-03 In distribution
G8024-913 In distribution
G8325-06 In distribution
X0018 In distribution
G8470-903 In distribution
G8421-03 In distribution
G8084-932 In distribution
F8384-12 In distribution
F8085-42 In distribution
G8424-933 In distribution
F8025-923 In distribution
G8325-02 In distribution
F8024-22 In distribution
G8424-916 In distribution
G8425-03 In distribution
G8325-22 In distribution
G0532-45 In distribution
F8424-922 In distribution
F8421-02 In distribution
G8010-916 In distribution
G8010-07 In distribution
G8425-912 In distribution
F8424-23 In distribution
F8125-13 In distribution
F8321-02 In distribution
F8481-902 In distribution
F8325-23 In distribution
G8385-907 In distribution
F8121-903 In distribution
G8485-23 In distribution
F8024-03 In distribution
F8125-912 In distribution
F8324-922 In distribution
F8325-12 In distribution
F8425-903 In distribution
G8425-903 In distribution
G8324-933 In distribution
F8084-912 In distribution
F8621-923 In distribution
G8184-922 In distribution
G8384-913 In distribution
G8121-02 In distribution
F8025-943 In distribution
G2846-02 In distribution
G8085-22 In distribution
F8424-07 In distribution
F8324-933 In distribution
F8024-13 In distribution
G8125-13 In distribution
F8470-902 In distribution
G8410-903 In distribution
G8185-923 In distribution
G8085-23 In distribution
F8325-13 In distribution
G8010-907 In distribution
F8325-906 In distribution
F8421-916 In distribution
G8424-22 In distribution
G0533-36 In distribution
G8084-02 In distribution
G8024-33 In distribution
F8425-902 In distribution
G8484-12 In distribution
F8085-923 In distribution
F8410-03 In distribution
G8410-906 In distribution
G8424-02 In distribution
F8425-907 In distribution
F8024-923 In distribution
G8485-13 In distribution
F8384-03 In distribution
G8421-06 In distribution
F8484-903 In distribution
G8384-906 In distribution
G8485-906 In distribution
G8124-02 In distribution
G8484-922 In distribution
F8681-16 In distribution
F8184-922 In distribution
F8024-902 In distribution
F8085-33 In distribution
F8024-33 In distribution
F8621-936 In distribution
G8410-902 In distribution
G8170-16 In distribution
G8085-13 In distribution
F8024-02 In distribution
F8084-933 In distribution
X0019 In distribution
G8010-16 In distribution
F8325-923 In distribution
G8425-923 In distribution
F8484-07 In distribution
G8321-912 In distribution
F8084-923 In distribution
G8325-03 In distribution
G8321-917 In distribution
G8485-923 In distribution
F8384-923 In distribution
F8510-02 In distribution
F8085-922 In distribution
A0761-51 In distribution
G8425-906 In distribution
G8010-903 In distribution
G8184-923 In distribution
G8184-03 In distribution
G8481-03 In distribution
G8384-13 In distribution
G8324-03 In distribution
F8470-02 In distribution
G8324-912 In distribution
F8621-933 In distribution
F8384-23 In distribution
G8185-02 In distribution
G8184-12 In distribution
G8125-913 In distribution
F8325-22 In distribution
F8421-902 In distribution
G8484-07 In distribution
G8124-22 In distribution
G8124-923 In distribution
G8070-06 In distribution
G8425-902 In distribution
F8024-32 In distribution
F8084-12 In distribution
F8325-02 In distribution
G8384-933 In distribution
F8470-03 In distribution
F8470-906 In distribution
G8385-923 In distribution
G8485-22 In distribution
G8025-02 In distribution
G8384-06 In distribution
G0535-45 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Tube, Orthodontic Forestadent Bernhard Förster GmbH 2,336
Generic Buccal Tubes American Orthodontics 799
Tube, Orthodontic G & H Wire Company 758
RMO RMO 697
Tube, Orthodontic Dentaurum GmbH & Co. KG 602
LP Low Profile American Orthodontics 506
3M™ Unitek™ Victory Series™ 3M Unitek 434
Buccal Tubes American Orthodontics 356
Peerless Buccal Tube Ormco Corporation 331
Empower Tube American Orthodontics 296
Mini Master Series American Orthodontics 289
ifit American Orthodontics 281

Showing 12 of 333. All products under Tube, 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