Legend
Legend LMI Vslot 018/022, BI-DIM, U5-5/L 5-5, 3
52manufacturers in China registered for this device type
1,098catalogue 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 | GC Orthodontics America Inc., United States |
|---|---|
| FDA product code | EJF |
| Device type | Bracket, Metal, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-29 |
| Record revised | 2021-09-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-01-16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 32-243D-0020 | 10 | In distribution | |
| 32-223D-0028 | 10 | In distribution | |
| 31-2540-0034 | 10 | In distribution | |
| 32-113D-0034 | 10 | In distribution | |
| 32-213D-0075 | 10 | In distribution | |
| 31-244D-0020 | 10 | In distribution | |
| 31-2230-D020 | 10 | In distribution | |
| 32-1340-0073 | 10 | In distribution | |
| 31-BCC3-4717 | 10 | In distribution | |
| 32-1130-0040 | 10 | In distribution | |
| 32-2340-0020 | 10 | In distribution | |
| 32-2540-0010 | 10 | In distribution | |
| 31-2310-0046 | 10 | In distribution | |
| 31-233D-0010 | 10 | In distribution | |
| 32-1540-0027 | 10 | In distribution | |
| 31-165U-0032 | 10 | In distribution | |
| 32-2210-0011 | 10 | In distribution | |
| 31-1110-0027 | 10 | In distribution | |
| 32-134D-0030 | 10 | In distribution | |
| 32-124M-0030 | 10 | In distribution | |
| 31-1220-0015 | 10 | In distribution | |
| 31-115U-0031 | 10 | In distribution | |
| 31-2230-0031 | 10 | In distribution | |
| 31-1430-0034 | 10 | In distribution | |
| 32-1450-0020 | 10 | In distribution | |
| 32-1550-0010 | 10 | In distribution | |
| 32-244D-0013 | 10 | In distribution | |
| 28-143D-0010 | 10 | In distribution | |
| 31-1CC5-D010 | In distribution | ||
| 31-164U-0033 | 10 | In distribution | |
| 32-1540-0010 | 10 | In distribution | |
| 32-1540-0011 | 10 | In distribution | |
| 38-2450-0073 | 10 | In distribution | |
| 32-115D-0020 | 10 | In distribution | |
| 31-1440-0010 | 10 | In distribution | |
| 31-133D-0010 | 10 | In distribution | |
| 31-2540-0035 | 10 | In distribution | |
| 32-235D-0010 | 10 | In distribution | |
| 32-2210-0020 | 10 | In distribution | |
| 32-2AA5-0168 | In distribution | ||
| 32-245D-0034 | 10 | In distribution | |
| 38-2650-0013 | 10 | In distribution | |
| 31-1220-0020 | 10 | In distribution | |
| 31-243D-0063 | 10 | In distribution | |
| 38-2330-0034 | 10 | In distribution | |
| 32-122D-0030 | 10 | In distribution | |
| 32-243D-0010 | 10 | In distribution | |
| 31-234D-0020 | 10 | In distribution | |
| 31-122D-0010 | 10 | In distribution | |
| 31-2LO3-X008 | 10 | In distribution | |
| 31-1410-0046 | 10 | In distribution | |
| 32-2110-0011 | 10 | In distribution | |
| 32-1CC3-9005 | In distribution | ||
| 31-1610-0020 | 10 | In distribution | |
| 31-2220-0034 | 10 | In distribution | |
| 31-222D-0010 | 10 | In distribution | |
| 32-113D-0010 | 10 | In distribution | |
| 32-1340-0030 | 10 | In distribution | |
| 32-122D-0010 | 10 | In distribution | |
| 32-1110-0027 | 10 | In distribution | |
| 31-1130-0010 | 10 | In distribution | |
| 32-2240-0030 | 10 | In distribution | |
| 31-1130-0034 | 10 | In distribution | |
| 31-1550-0031 | 10 | In distribution | |
| 31-2CC5-4794 | 10 | In distribution | |
| 27-113D-0012 | 10 | In distribution | |
| 38-144D-0073 | 10 | In distribution | |
| 32-2650-0013 | 10 | In distribution | |
| 31-2BB5-0020 | 10 | In distribution | |
| 32-213D-0010 | 10 | In distribution | |
| 31-112D-0010 | 10 | In distribution | |
| 31-1AA3-5941 | In distribution | ||
| 31-2150-0010 | 10 | In distribution | |
| 32-1610-0010 | 10 | In distribution | |
| 32-1CC5-2991 | 10 | In distribution | |
| 38-224M-0034 | 10 | In distribution | |
| 31-2430-0010 | 10 | In distribution | |
| 27-1410-0010 | 10 | In distribution | |
| 38-234D-0013 | 10 | In distribution | |
| 31-2210-GP10 | 10 | In distribution | |
| 31-213D-GP20 | 10 | In distribution | |
| 31-1650-0013 | 10 | In distribution | |
| 31-2540-0025 | 10 | In distribution | |
| 32-2610-0034 | 10 | In distribution | |
| 32-1350-0022 | 10 | In distribution | |
| 31-254U-0032 | 10 | In distribution | |
| 31-2210-0031 | 10 | In distribution | |
| 31-134D-0073 | 10 | In distribution | |
| 32-2CC5-M020 | In distribution | ||
| 32-2130-0030 | 10 | In distribution | |
| 31-133D-0021 | 10 | In distribution | |
| 38-2210-0020 | 10 | In distribution | |
| 31-1120-0011 | 10 | In distribution | |
| 32-133D-0021 | 10 | In distribution | |
| 31-2210-0027 | 10 | In distribution | |
| 32-244D-0040 | 10 | In distribution | |
| 32-1CC5-0010 | 10 | In distribution | |
| 32-2CC30020 | 10 | In distribution | |
| 31-2230-0020 | 10 | In distribution | |
| 32-10C5-0010 | In distribution | ||
| 32-143D-0040 | 10 | In distribution | |
| 31-2640-0035 | 10 | In distribution | |
| 31-1220-0010 | 10 | In distribution | |
| 31-123U-0031 | 10 | In distribution | |
| 31-X001 | 10 | In distribution | |
| 32-2550-0020 | 10 | In distribution | |
| 38-1CC3-0021 | In distribution | ||
| 31-2340-GP10 | 10 | In distribution | |
| 32-1450-0022 | 10 | In distribution | |
| 31-224D-0020 | 10 | In distribution | |
| 31-242D-0010 | 10 | In distribution | |
| 31-1210-0020 | 10 | In distribution | |
| 32-1140-0030 | 10 | In distribution | |
| 31-135D-0020 | 10 | In distribution | |
| 38-1120-0034 | 10 | In distribution | |
| 31-2250-GP10 | 10 | In distribution | |
| 31-X1256 | 10 | In distribution | |
| 31-2550-0020 | 10 | In distribution | |
| 38-2640-0034 | 10 | In distribution | |
| 32-1230-0034 | 10 | In distribution | |
| 31-2GP5-10946 | In distribution | ||
| 32-145D-0073 | 10 | In distribution | |
| 31-1150-0032 | 10 | In distribution | |
| 31-1210-0027 | 10 | In distribution | |
| 32-135D-0010 | 10 | In distribution | |
| 32-235D-0034 | 10 | In distribution | |
| 32-1610-0030 | 10 | In distribution | |
| 31-2AA5-X8723 | In distribution | ||
| 38-2430-0034 | 10 | In distribution | |
| 31-2220-GP10 | 10 | In distribution | |
| 32-2230-0034 | 10 | In distribution | |
| 31-235D-0020 | 10 | In distribution | |
| 31-132U-0046 | 10 | In distribution | |
| 31-124M-0010 | 10 | In distribution | |
| 31-2430-0031 | 10 | In distribution | |
| 32-243D-0028 | 10 | In distribution | |
| 31-145D-0034 | 10 | In distribution | |
| 31-1110-0015 | 10 | In distribution | |
| 32-2130-0020 | 10 | In distribution | |
| 31-164U-0048 | 10 | In distribution | |
| 31-113D-0021 | 10 | In distribution | |
| 31-1310-0045 | 10 | In distribution | |
| 32-1210-0027 | 10 | In distribution | |
| 38-224D-0020 | 10 | In distribution | |
| 38-213D-0021 | 10 | In distribution | |
| 38-2CC4-0010 | In distribution | ||
| 32-234D-0040 | 10 | In distribution | |
| 31-145D-0025 | 10 | In distribution | |
| 32-224M-0020 | 10 | In distribution | |
| 32-115M-0010 | 10 | In distribution | |
| 32-1210-0010 | 10 | In distribution | |
| 31-1120-0031 | 10 | In distribution | |
| 31-2350-0010 | 10 | In distribution | |
| 32-2540-0013 | 10 | In distribution | |
| 38-1340-0073 | 10 | In distribution | |
| 31-114M-0034 | 10 | In distribution | |
| 38-1650-0013 | 10 | In distribution | |
| 31-2640-0039 | 10 | In distribution | |
| 31-244D-0073 | 10 | In distribution | |
| 32-135D-0073 | 10 | In distribution | |
| 32-123D-0027 | 10 | In distribution | |
| 38-BID3-0034 | In distribution | ||
| 31-1540-0013 | 10 | In distribution | |
| 32-213D-0015 | 10 | In distribution | |
| 31-2340-0020 | 10 | In distribution | |
| 32-234D-0020 | 10 | In distribution | |
| 32-2BB5-0106 | In distribution | ||
| 32-2BB5-8993 | In distribution | ||
| 31-1450-0010 | 10 | In distribution | |
| 32-2CC0-0010 | 10 | In distribution | |
| 31-213D-0063 | 10 | In distribution | |
| 32-143D-0028 | 10 | In distribution | |
| 31-2640-0034 | 10 | In distribution | |
| 38-1210-0020 | 10 | In distribution | |
| 31-2CC3-0034 | 10 | In distribution | |
| 28-1120-0010 | 10 | In distribution | |
| 31-2BB4-5958 | In distribution | ||
| 31-113D-0027 | 10 | In distribution | |
| 31-233D-GP10 | 10 | In distribution | |
| 31-1CC2-6587 | In distribution | ||
| 38-1220-0020 | 10 | In distribution | |
| 32-133D-0020 | 10 | In distribution | |
| 31-1610-0037 | 10 | In distribution | |
| 31-2340-0073 | 10 | In distribution | |
| 31-1CC3-0010 | 10 | In distribution | |
| 38-214D-0020 | 10 | In distribution | |
| 31-1250-0031 | 10 | In distribution | |
| 31-2610-0031 | 10 | In distribution | |
| 31-244D-GP10 | 10 | In distribution | |
| 38-1BB5-5959 | In distribution | ||
| 32-1640-0029 | 10 | In distribution | |
| 31-BID3-0040 | In distribution | ||
| 31-2BB5-0119 | In distribution | ||
| 31-2650-0039 | 10 | In distribution | |
| 31-1110-0034 | 10 | In distribution | |
| 32-1350-0073 | 10 | In distribution | |
| 31-2640-0032 | 10 | In distribution | |
| 38-234D-0073 | 10 | In distribution | |
| 28-1210-0010 | 10 | In distribution | |
| 31-2210-0020 | 10 | In distribution | |
| 31-1250-0032 | 10 | In distribution | |
| 32-1120-0027 | 10 | In distribution | |
| 31-X3020 | 10 | In distribution | |
| 32-244D-0020 | 10 | In distribution | |
| 32-234D-0073 | 10 | In distribution | |
| 32-X2991 | 10 | In distribution | |
| 32-114M-0013 | 10 | In distribution | |
| 31-1410-0045 | 10 | In distribution | |
| 38-2CC5-9200 | In distribution | ||
| 31-123D-0011 | 10 | In distribution | |
| 32-2210-0010 | 10 | In distribution | |
| 38-2350-0073 | 10 | In distribution | |
| 31-235D-0013 | 10 | In distribution | |
| 31-233U-0031 | 10 | In distribution | |
| 32-2430-0020 | 10 | In distribution | |
| 32-2CC4-9071 | In distribution | ||
| 32-2640-0013 | 10 | In distribution | |
| 38/31-1B34-3969 | In distribution | ||
| 32-245D-0010 | 10 | In distribution | |
| 31-2650-0035 | 10 | In distribution | |
| 32-2120-0020 | 10 | In distribution | |
| 32-113D-0020 | 10 | In distribution | |
| 31-144D-0025 | 10 | In distribution | |
| 38-245D-0013 | 10 | In distribution | |
| 31-2130-0034 | 10 | In distribution | |
| 31-224M-0013 | 10 | In distribution | |
| 27-123D-0012 | 10 | In distribution | |
| 31-114M-0010 | 10 | In distribution | |
| 31-243D-0020 | 10 | In distribution | |
| 32-134D-0020 | 10 | In distribution | |
| 31-213D-0034 | 10 | In distribution | |
| 31-223D-D020 | 10 | In distribution | |
| 31-1340-0020 | 10 | In distribution | |
| 32-2CC3-0034 | 10 | In distribution | |
| 32-124D-0020 | 10 | In distribution | |
| 32-2340-0030 | 10 | In distribution | |
| 31-2640-0013 | 10 | In distribution | |
| 38-2AA5-0021 | In distribution | ||
| 38-2350-0020 | 10 | In distribution | |
| 38-1A34-3969 | In distribution | ||
| 27-1210-0010 | 10 | In distribution | |
| 31-135D-0034 | 10 | In distribution | |
| 31-2220-0010 | 10 | In distribution | |
| 32-233D-0028 | 10 | In distribution | |
| 31-233D-GP20 | 10 | In distribution | |
| 38-2230-0034 | 10 | In distribution | |
| 27-143D-0010 | 10 | In distribution | |
| 31-225M-0010 | 10 | In distribution | |
| 32-1440-0073 | 10 | In distribution | |
| 38-2B34-3050 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Stainless Steel Brackets | American Orthodontics | 612 |
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.