Leone SPA
BRACKET POSITIONING GAUGE 5-5,5mm PURPLE
30manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (6), Zhejiang (6). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Envista (Suzhou) Medical Device Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Envista (Sichuan) Medical Device Co., Ltd. | Ziyang | Sichuan | Contract manufacturer | 4 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Wellmed Dental Medical Supply Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 37 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Showing 12 of 30. All 30 manufacturers in China registered for Aligner, Bracket, Orthodontic
Record
| Listed by | Leone SPA, Italy |
|---|---|
| FDA product code | ECQ |
| Device type | Aligner, Bracket, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-05-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P1604-00 | In distribution | |
| P1603-00 | In distribution | |
| P1602-00 | In distribution | |
| P1601-00 | In distribution | |
| P1600-95 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ortho Arch | Ortho Arch Company Inc | 14 |
| Weldable Lingual | Ortho Arch Company Inc | 4 |
| DTC | Hangzhou DTC Medical Apparatus Co., Ltd. | 3 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 2 |
| Lingual Cleat | Ortho Arch Company Inc | 2 |
| TBS Basics | Acme Enterprise. | 2 |
| J&J Instruments | J & J Instruments, LLC | 2 |
| Henry Schein | Henry Schein, Inc. | 2 |
| Keats Tweezers | Ortho Organizers, Inc. | 2 |
| Direct Bond | Ortho Arch Company Inc | 2 |
| Direct Bond Button | Ortho Arch Company Inc | 1 |
| Smilegoods Aligner Chewies Mint 24 Pack | Practicon, Inc. | 1 |
Showing 12 of 39. All products under Aligner, Bracket, 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.