Alpine SL
Alpine SL BIO 018 MX/MN R/L BIC 0A 0T (NO HOOK)
52manufacturers in China registered for this device type
65catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (19), Guangdong (11), Jiangsu (9). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Chengdu Sani Medical Equipment Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 12 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Yancheng Denrum Medical Apparatus Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 5 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
Showing 12 of 52. All 52 manufacturers in China registered for Bracket, Metal, Orthodontic
Record
| Listed by | RMO, United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| M22114 | 10 | In distribution | |
| M22120 | 10 | In distribution | |
| M22130 | 10 | In distribution | |
| M22407 | 10 | In distribution | |
| M22411 | 10 | In distribution | |
| M22262 | 10 | In distribution | |
| M22100 | 10 | In distribution | |
| M22263 | 10 | In distribution | |
| M12200 | 10 | In distribution | |
| M22420 | 10 | In distribution | |
| M22406 | 10 | In distribution | |
| KM22201 | In distribution | ||
| M22127 | 10 | In distribution | |
| M22135 | 10 | In distribution | |
| M22102 | 10 | In distribution | |
| M22252 | 10 | In distribution | |
| M22427 | 10 | In distribution | |
| M22110 | 10 | In distribution | |
| M22260 | 10 | In distribution | |
| KM22261 | In distribution | ||
| M22103 | 10 | In distribution | |
| M12210 | 10 | In distribution | |
| M22208 | 10 | In distribution | |
| M22253 | 10 | In distribution | |
| M22251 | 10 | In distribution | |
| M22115 | 10 | In distribution | |
| M22111 | 10 | In distribution | |
| M22126 | 10 | In distribution | |
| M12207 | 10 | In distribution | |
| M22430 | 10 | In distribution | |
| M12201 | 10 | In distribution | |
| M22426 | 10 | In distribution | |
| M22201 | 10 | In distribution | |
| M22206 | 10 | In distribution | |
| KM22251 | In distribution | ||
| M22434 | 10 | In distribution | |
| M22207 | 10 | In distribution | |
| M22400 | 10 | In distribution | |
| M12220 | 10 | In distribution | |
| M22220 | 10 | In distribution | |
| M22431 | 10 | In distribution | |
| M22401 | 10 | In distribution | |
| KM22102 | In distribution | ||
| M22107 | 10 | In distribution | |
| M22402 | 10 | In distribution | |
| M22410 | 10 | In distribution | |
| M22414 | 10 | In distribution | |
| M22415 | 10 | In distribution | |
| M22403 | 10 | In distribution | |
| KM22402 | In distribution | ||
| M12202 | 10 | In distribution | |
| M22200 | 10 | In distribution | |
| M12203 | 10 | In distribution | |
| M22202 | 10 | In distribution | |
| M22261 | 10 | In distribution | |
| M12206 | 10 | In distribution | |
| M12211 | 10 | In distribution | |
| M22134 | 10 | In distribution | |
| M22435 | 10 | In distribution | |
| KM12202 | 20 | In distribution | |
| M22203 | 10 | In distribution | |
| M22106 | 10 | In distribution | |
| M22131 | 10 | In distribution | |
| M22101 | 10 | In distribution | |
| M22250 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leone SPA | Leone SPA | 2,306 |
| BioQuick® | Forestadent Bernhard Förster GmbH | 1,842 |
| Mini Master Series | American Orthodontics | 1,505 |
| Mini-Mono® | Forestadent Bernhard Förster GmbH | 1,225 |
| LP Low Profile | American Orthodontics | 1,204 |
| Mini Sprint® | Forestadent Bernhard Förster GmbH | 1,193 |
| Empower Bracket | American Orthodontics | 1,175 |
| Legend | GC Orthodontics America Inc. | 1,098 |
| Master Series | American Orthodontics | 1,084 |
| Experience® | GC Orthodontics America Inc. | 770 |
| The Orthodontic Store | Young Innovations Inc. | 658 |
| equilibrium® | Dentaurum GmbH & Co. KG | 646 |
Showing 12 of 876. All products under Bracket, Metal, Orthodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K902050 | 1990-08-03 |
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.