Leone SPA

Mini LIP Bumper Veltri W/Stop Adjustable

Registry build 21.09.26
3manufacturers in China registered for this device type
91catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Guangdong (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code EHP
Manufacturer City Province Registered as Device types
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Fseven Dental Technology Zhuhai Co., Ltd. Zhuhai Guangdong Manufacturer 18
Yamahachi Dental Material (Changshu) Co., Ltd. Changshu Jiangsu Manufacturer 9

Record

Regulatory record for Leone SPA
Listed by Leone SPA, Italy
FDA product code EHP
Device type Clasp, Preformed
Device class Class 1
Regulation 21 CFR 872.3285
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-04-16

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
M3051-03 In distribution
C0570-952 In distribution
C0585-50 In distribution
C0585-25 In distribution
C0570-946 In distribution
C0570-48 In distribution
C0576-38 In distribution
C0570-936 In distribution
M3052-00 In distribution
M3051-02 In distribution
C0576-946 In distribution
C0570-944 In distribution
M3051-01 In distribution
C0585-48 In distribution
C0576-46 In distribution
C0576-36 In distribution
C0580-12 In distribution
C0576-936 In distribution
M3051-013 In distribution
M3053-02 In distribution
C0580-95 In distribution
M3053-012 In distribution
C0576-48 In distribution
C0570-940 In distribution
C0585-95 In distribution
C0576-952 In distribution
C0576-934 In distribution
C0576-940 In distribution
C1610-18 In distribution
C0570-38 In distribution
C0576-40 In distribution
C0570-938 In distribution
C0570-942 In distribution
M3053-014 In distribution
C0580-08 In distribution
C0576-96 In distribution
M3051-04 In distribution
M3051-00 In distribution
C0570-42 In distribution
C0576-34 In distribution
C0580-11 In distribution
M3053-05 In distribution
C0576-50 In distribution
C0580-06 In distribution
C0576-44 In distribution
C0580-09 In distribution
C0570-36 In distribution
C0570-46 In distribution
C0576-950 In distribution
A1730-07 In distribution
M3051-014 In distribution
C0576-52 In distribution
C0570-934 In distribution
C0576-938 In distribution
C0580-065 In distribution
C1610-19 In distribution
M3050-00 In distribution
C0570-40 In distribution
C0576-42 In distribution
C0576-944 In distribution
M3053-04 In distribution
C0585-34 In distribution
M3053-013 In distribution
C0585-28 In distribution
C0580-05 In distribution
C0570-96 In distribution
C0585-40 In distribution
C0570-948 In distribution
C0570-950 In distribution
C0570-44 In distribution
M3051-011 In distribution
C0585-37 In distribution
M3053-03 In distribution
C0585-31 In distribution
C0576-942 In distribution
M3053-01 In distribution
C0585-46 In distribution
C0576-948 In distribution
C0570-34 In distribution
M3051-012 In distribution
C0570-52 In distribution
C0580-07 In distribution
C0585-43 In distribution
C0580-055 In distribution
C0570-50 In distribution
M3051-05 In distribution
C0580-10 In distribution
M3053-011 In distribution
M3053-015 In distribution
C1610-17 In distribution
M3051-015 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Noninium® Dentaurum GmbH & Co. KG 27
Zirlux Henry Schein, Inc. 27
Keystone Industries Keystone Industries 26
Therm-o-Flex® Dentsply LLC 20
SCHEU-Anchor Scheu-Dental Gmbh 15
Clasp, Preformed Forestadent Bernhard Förster GmbH 14
Clasp, Preformed Dentaurum GmbH & Co. KG 13
Adams Clasp Scheu-Dental Gmbh 12
RMO RMO 12
J-Clasp Scheu-Dental Gmbh 7
J-Clasp oblique Scheu-Dental Gmbh 6
ItsoClear Keystone Industries 5

Showing 12 of 24. All products under Clasp, Preformed

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