Eclipse Passive
022 Ubil Eclipse Passive SLB Roth -7T HK (5)
52manufacturers in China registered for this device type
63catalogue numbers in this listing
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 | Ortho Arch Company Inc, United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-06-21 |
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 number | Size | Status |
|---|---|---|
| 463-201 | In distribution | |
| 463-002 | In distribution | |
| 463-352 | In distribution | |
| 463-045 | In distribution | |
| 463-132 | In distribution | |
| 463-102 | In distribution | |
| 463-362 | In distribution | |
| 463-372 | In distribution | |
| 463-072 | In distribution | |
| 463-904 | In distribution | |
| 463-312 | In distribution | |
| 463-061 | In distribution | |
| 463-032 | In distribution | |
| 463-311 | In distribution | |
| 463-331 | In distribution | |
| 463-122 | In distribution | |
| 463-101 | In distribution | |
| 463-022 | In distribution | |
| 463-261 | In distribution | |
| 463-161 | In distribution | |
| 463-112 | In distribution | |
| 463-151 | In distribution | |
| 463-062 | In distribution | |
| 463-902 | In distribution | |
| 463-212 | In distribution | |
| 463-012 | In distribution | |
| 463-245 | In distribution | |
| 463-172 | In distribution | |
| 463-171 | In distribution | |
| 463-252 | In distribution | |
| 463-251 | In distribution | |
| 463-332 | In distribution | |
| 463-202 | In distribution | |
| 463-903 | In distribution | |
| 463-271 | In distribution | |
| 463-301 | In distribution | |
| 463-145 | In distribution | |
| 463-221 | In distribution | |
| 463-051 | In distribution | |
| 463-232 | In distribution | |
| 463-272 | In distribution | |
| 463-321 | In distribution | |
| 463-211 | In distribution | |
| 463-231 | In distribution | |
| 463-901 | In distribution | |
| 463-351 | In distribution | |
| 463-071 | In distribution | |
| 463-152 | In distribution | |
| 463-345 | In distribution | |
| 463-322 | In distribution | |
| 463-222 | In distribution | |
| 463-361 | In distribution | |
| 463-131 | In distribution | |
| 463-111 | In distribution | |
| 463-162 | In distribution | |
| 463-262 | In distribution | |
| 463-121 | In distribution | |
| 463-011 | In distribution | |
| 463-021 | In distribution | |
| 463-031 | In distribution | |
| 463-052 | In distribution | |
| 463-371 | In distribution | |
| 463-302 | 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
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.