Smilegoods Aligner Chewies Assorted 24 Pack
Catalogue number 71098133 AST, listed by Practicon, Inc., United States, under Aligner, Bracket, Orthodontic. 30 manufacturers in China are registered for this product code.
30manufacturers in China registered for this device type
1catalogue number
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 | Practicon, Inc., United States |
|---|---|
| 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 | 2024-08-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71098133 AST | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ortho Arch | Ortho Arch Company Inc | 14 |
| Leone SPA | Leone SPA | 5 |
| 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 |
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.